PaxMed achieves 302nd
510(k) clearance
The list below will give you an idea of the scope of our 510(k) work.
K Number | Date | Company | Product Name | Product Code | 510K Review Panel | FDA Link |
|---|---|---|---|---|---|---|
| K243128 | 2024-12-18 | SOADCO S.L. | Klockner Kits | KCT | Dental | TBD |
| K242340 | 2024-11-05 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242340 |
| K241170 | 2024-10-21 | Talladium España, SL | Dynamic TiBase; TRI Screws | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241170 |
| K242372 | 2024-10-18 | Bone Solutions | Mg OSTEOREVIVE™, Mg OSTEOCRETE™ | MQV, OIS, MBP | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242372 |
| K240262 | 2024-10-10 | B.T.I. Biotechnology Institute, S.L. | BTI Interna 3.0 Dental Implant System UnicCa® | DZE, Nha | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240262 |
| K231566 | 2024-09-05 | medentis medical GmbH | ICX-Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231566 |
| K240609 | 2024-07-17 | S.I.N. – Sistema de Implante Nacional S.A. | S.I.N. Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240609 |
| K240187 | 2024-06-05 | BioHorizons Implant Systems, Inc. | Tapered Pro Conical Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240187 |
| K233008 | 2024-06-05 | aap Implantate AG | Cannulated Headless Bone Screws | HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233008 |
| K232821 | 2024-05-31 | S.I.N. – Sistema de Implante Nacional S.A. | S.I.N. Dental Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232821 |
| K240208 | 2024-04-24 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240208 |
| K234013 | 2024-02-05 | Bone Solutions | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ | MQV, OIS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K234013 |
| K233316 | 2024-01-05 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233316 |
| K223714 | 2023-12-29 | Adin Dental Implants Systems Ltd | UniFit Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223714 |
| K231127 | 2023-12-07 | S.I.N. – Sistema de Implante Nacional S.A. | S.I.N. Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231127 |
| K231559 | 2023-11-17 | Talladium España, SL | Multi-Unit DAS System | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231559 |
| K232151 | 2023-10-17 | Talladium España, SL | Dynamic TiBase | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232151 |
| K231827 | 2023-09-15 | B.T.I. Biotechnology Institute, S.L. | BTI Dental Implant System UnicCa® – Aesthetic Post Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231827 |
| K231455 | 2023-08-15 | Implant Logistics | Implant-One™ System | NHA, PNP | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231455 |
| K231434 | 2023-08-14 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231434 |
| K230971 | 2023-06-02 | Medartis AG | APTUS® 3.5 TriLock Straight Plates | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230971 |
| K222560 | 2023-05-16 | Incisive Technologies Pty Ltd | BlueCheck™ Caries Detection & Monitoring | LFC | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222560 |
| K230103 | 2023-04-23 | SOADCO S.L. | Klockner Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230103 |
| K230143 | 2023-04-13 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230143 |
| K230069 | 2023-04-06 | S.I.N. – Sistema de Implante Nacional S.A. | S.I.N. Dental Implant System | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230069 |
| K212394 | 2023-03-23 | Implant Logistics, Inc. | Implant-One™ Multi-Unit Abutment | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212394 |
| K230141 | 2023-03-17 | aap Implantate AG | LOQTEQ® VA Elbow Plates 2.7/3.5 System | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230141 |
| K221301 | 2023-03-09 | Terrats Medical SL | DESS Dental Smart Solutions | NHA, PNP | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221301 |
| K222984 | 2022-12-29 | BioClean Dental, LLC | BioClean Implant Restorative System | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222984 |
| K221453 | 2022-12-15 | S.I.N. – Sistema de Implante Nacional S.A. | S.I.N. Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221453 |
| K222368 | 2022-12-01 | Imagine Milling Technologies | MIST IC | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222368 |
| K222231 | 2022-10-27 | S.I.N. – Sistema de Implante Nacional S.A. | S.I.N. Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222231 |
| K222288 | 2022-10-27 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222288 |
| K222514 | 2022-10-27 | S.I.N. – Sistema de Implante Nacional S.A. | S.I.N. Instrument Kits | KCT | General Hospital | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222514 |
| K222269 | 2022-10-25 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222269 |
| K222005 | 2022-09-29 | S.I.N. – Sistema de Implante Nacional S.A. | S.I.N. Instrument Kits | KCT | General Hospital | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222005 |
| K221966 | 2022-09-15 | Talladium España, SL | Dynamic TiBase | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221966 |
| K213576 | 2022-07-15 | Tatum Surgical | Tatum Surgical Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213576 |
| K220771 | 2022-07-07 | Stratasys Ltd | Stratasys TrueDent | EBI, EBG, PZY, EBF | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220771 |
| K221019 | 2022-07-05 | Osteon Medical (Implant Solutions PTY LTD) | Osteon Precision Milled Suprastructure | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221019 |
| K221256 | 2022-06-28 | Bone Solutions | Mg OSTEOINJECT™ | NHA | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221256 |
| K220612 | 2022-06-06 | Innovative Product Brands, Inc | PrimeLOC Attachment System | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220612 |
| K212628 | 2022-03-11 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212628 |
| K212676 | 2022-03-03 | Osteon Medical (Implant Solutions PTY LTD) | Osteon Precision Milled Suprastructure | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212676 |
| K213599 | 2022-02-23 | Dentium Co., Ltd | SuperLine | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213599 |
| K212991 | 2022-01-21 | Bone Solutions | OSTEOREVIVE™ | MQV, OIS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212991 |
| K213391 | 2022-01-11 | Zest Anchors, LLC | High Retention Attachment System | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213391 |
| K203660 | 2021-12-21 | TRI Dental Implants Int. AG | TRI-matrix® Implant Line | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203660 |
| K212538 | 2021-12-14 | Terrats Medical SL | DESS Dental Implants | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212538 |
| K212577 | 2021-12-10 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212577 |
| K212068 | 2021-11-08 | Biotech Dental, SAS | Biotech Dental Kits | KCT | General Hospital | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212068 |
| K212404 | 2021-11-02 | S.I.N. – Sistema de Implante Nacional S.A. | S.I.N. Instrument Kits | KCT | General Hospital | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212404 |
| K211921 | 2021-10-20 | S.I.N. – Sistema de Implante Nacional S.A. | S.I.N. Dental Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211921 |
| K211582 | 2021-10-18 | aap Implantate AG | LOQTEQ® Proximal Humerus Plate 3.5 System | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211582 |
| K212108 | 2021-09-24 | Talladium España, SL | Dynamic TiBase | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212108 |
| K203464 | 2021-08-04 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203464 |
| K203725 | 2021-06-23 | S.I.N. – Sistema de Implante Nacional S.A. | S.I.N. Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K203725 |
| K210220 | 2021-06-18 | Biotech Dental, SAS | Kontact™ Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210220 |
| K203240 | 2021-04-27 | Integrated Dental Systems | AccelX™ Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203240 |
| K201878 | 2021-03-25 | Z-Systems AG | St-z5 Kits | KCT | General Hospital | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201878 |
| K203252 | 2021-03-16 | BioHorizons Implant Systems, Inc. | Multi-unit Abutments for CONELOG® | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203252 |
| K210043 | 2021-03-03 | aap Implantate AG | LOQTEQ® Distal Lateral Femur Plate 4.5 System | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210043 |
| K202026 | 2020-12-18 | Blue Sky Bio | Blue Sky Bio CAD-CAM Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202026 |
| K201712 | 2020-12-01 | Z-Systems AG | Z5-TL | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201712 |
| K200992 | 2020-11-17 | S.I.N. – Sistema De Implante Nacional S.A. | S.I.N. Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200992 |
| K202589 | 2020-11-06 | Medartis AG | APTUS® Cannulated Compression Screws, APTUS® Headed Cannulated Screws, APTUS® K-Wire System | HWC, HTY, HTN | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K202589 |
| K201688 | 2020-10-21 | S.I.N. – Sistema De Implante Nacional S.A. | S.I.N. Instrument Kits | KCT | General Hospital | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201688 |
| K200386 | 2020-10-14 | Z-Systems AG | Z5-BL | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200386 |
| K200355 | 2020-07-22 | Elegant Dental | Duranext Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200355 |
| K193075 | 2020-06-09 | SIRAKOSS Ltd | Osteo3 ZP Putty | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K193075 |
| K193096 | 2020-05-14 | S.I.N. – Sistema De Implante Nacional S.A. | Endosseous Dental Implant | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K193096 |
| K193639 | 2020-03-26 | Medartis AG | APTUS® Foot 2.8-3.5 System | HRS, HWC, PLF | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K193639 |
| K193633 | 2020-03-26 | Medartis AG | APTUS® Ankle Trauma System 2.8/3.5 | HRS, HWC, HTN | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K193633 |
| K193554 | 2020-02-16 | Medartis AG | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K193554 |
| K191919 | 2020-02-10 | Elos Medtech Pinol A/S | Accurate® Hybrid Base™ | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191919 |
| K192984 | 2020-01-24 | Medartis AG | APTUS® Clavicle System | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192984 |
| K190243 | 2020-01-03 | Z-Systems AG | Implant, Endosseous, Root Form | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190243 |
| K190552 | 2019-12-06 | JJ Implants | Endosseous Dental Implant | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190552 |
| K191986 | 2019-11-10 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191986 |
| K192297 | 2019-11-08 | Medartis, AG | APTUS® Wrist Arthrodesis Plates | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192297 |
| K191848 | 2019-09-30 | Medartis, AG | APTUS® Wrist Spanning Plates 2.5 | HRS, HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191848 |
| K191636 | 2019-08-16 | Medartis, AG | APTUS® Foot System | JDR | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191636 |
| K190491 | 2019-08-12 | Blue Sky Bio | Blue Sky Bio Zygomatic Implant System | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190491 |
| K191222 | 2019-08-05 | Prismatik Dentalcraft, Inc. | Inclusive® Titanium Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191222 |
| K182246 | 2019-04-16 | Imagine Milling Technologies | MIST IC | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182246 |
| K180924 | 2019-03-29 | Integrated Dental Systems | Reflect™ Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180924 |
| K183518 | 2019-03-18 | Preat Corporation | Endosseous Dental Implant Abutment | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183518 |
| K180204 | 2018-12-28 | Visionare, LLC | CranioMaxillofacial Fixation (CMF) System – CMF Visionare | JEY, DZL | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180204 |
| K181850 | 2018-11-14 | Southern Implants (Pty) Ltd. | Inversa Implants | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181850 |
| K181721 | 2018-09-17 | Curasan AG | Ceracell Ortho Foam | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181721 |
| K180465 | 2018-09-06 | Southern Implants (Pty) Ltd. | Provata Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180465 |
| K180536 | 2018-08-30 | Neodent | GM Line Additions | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180536 |
| K181009 | 2018-08-24 | Medartis, AG | APTUS® CMC-I Fusion System | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181009 |
| K181425 | 2018-08-05 | Medartis, AG | APTUS® Proximal Humerus System | HRS, HTY, HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181425 |
| K173908 | 2018-06-15 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173908 |
| K173902 | 2018-04-20 | Neodent | Neodent Implant System – GM Line | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173902 |
| K173525 | 2018-04-06 | OsteoNovus, Inc. | NovoGro | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173525 |
| K171713 | 2018-04-05 | Neodent | Neodent Instrument Kits | KCT | General Hospital | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171713 |
| K173343 | 2018-02-27 | Southern Implants (Pty) Ltd. | Zygomatic Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173343 |
| K171622 | 2018-01-11 | Dentium Co., Ltd | Dentium Ti-Base | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171622 |
| K172573 | 2017-12-15 | Orthorebirth Co., Ltd | ReBOSSIS85 | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172573 |
| K173374 | 2017-12-13 | Biomet 3i | TSV BellaTek Encode Healing Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173374 |
| K170392 | 2017-12-01 | S.I.N. – Sistema De Implante Nacional S.A. | S.I.N. Dental Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170392 |
| K170398 | 2017-11-21 | S.I.N. – Sistema De Implante Nacional S.A. | S.I.N. Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170398 |
| K163634 | 2017-11-06 | Southern Implants (Pty) Ltd. | External Hex Implants | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163634 |
| K171795 | 2017-09-29 | Thommen Medical, AG | Thommen Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171795 |
| K172170 | 2017-09-08 | Medartis, AG | APTUS® Wrist 2.5 System | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172170 |
| K170588 | 2017-08-08 | Terrats Medical SL | DESS Dental Smart Solutions | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170588 |
| K170620 | 2017-06-23 | Orthorebirth Co., Ltd | REBOSSIS85 | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170620 |
| K162087 | 2017-04-18 | OsteoNovus, Inc. | NovoGro | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162087 |
| K161861 | 2017-02-09 | Medartis, AG | APTUS® Coronoid 2.0 | HRS | Orthopedic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161861 |
| K162677 | 2016-12-21 | Rhondium, Ltd. | L-OVC | EIH | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162677 |
| K161713 | 2016-12-16 | Dentium Co., Ltd | Dentium CAD/CAM Abutments | NHA | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161713 |
| K160786 | 2016-11-21 | Rodo Medical, Inc. | Rodo Abutment System | NHA | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160786 |
| K160979 | 2016-11-04 | Prismatik Dentalcraft, Inc. | Inclusive® Abutments | NHA | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160979 |
| K160784 | 2016-09-14 | Camlog | CAM Titanium Blanks | NHA | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160784 |
| K153274 | 2016-08-04 | Snyder Industries, Inc. | Med-Tainer Single Deposit Container (SDC) | MMK | General Hospital | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153274 |
| K160244 | 2016-06-02 | Thommen Medical, AG | VARIOunite | NHA | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160244 |
| K153064 | 2016-04-29 | Blue Sky Bio | Blue Sky Bio Zygomatic Implant System | DZE, NHA | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153064 |
| K153779 | 2016-03-31 | Camlog | Abutment for Bridges | NHA | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153779 |
| K151984 | 2016-03-10 | Thommen Medical, AG | Milling Abutment for CAD/CAM | NHA | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151984 |
| K151789 | 2016-03-04 | Zest Anchors, LLC | LOCATOR F-Tx Attachment System | NHA | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151789 |
| K152568 | 2016-02-11 | Cardinal Spine | C-VBR | PLR | Orthopedic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152568 |
| K152509 | 2016-01-12 | Camlog | CAMLOG® and CONELOG® Abutments For Screw-retained Restorations (ASR) | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K152509 |
| K151916 | 2015-12-18 | Tri Dental Implants Int. AG | TRI® Dental Implant System | DZE, NHA | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151916 |
| K150203 | 2015-10-23 | Medentika GmbH | CAD/CAM Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150203 |
| K151599 | 2015-10-02 | Camlog | iSy® Implant System | DZE, NHA | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151599 |
| K150021 | 2015-07-31 | Z-Systems | Z5m(t) | DZE | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150021 |
| K150295 | 2015-07-24 | Zest Anchors, LLC | LOCATOR RTx | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150295 |
| K141777 | 2015-07-20 | Neodent | Neodent Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141777 |
| K150367 | 2015-07-13 | Neodent | Neodent Implant System | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150367 |
| K150199 | 2015-06-15 | Neodent | Neodent Implant System | DZE, NHA | Dental | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150199 |
| K142906 | 2015-06-09 | Medartis, AG | APTUS® Wrist 2.5 System | HRS, HWC | Orthopedic | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142906 |
| K143694 | 2015-05-15 | Rhondium, Ltd. | One-Visit-Crown | EBF | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K143694 |
| K142581 | 2015-04-09 | Medartis, AG | APTUS® Foot System | HRS, HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142581 |
| K142167 | 2015-02-20 | Medentika GmbH | Medentika Abutment System | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142167 |
| K143337 | 2015-02-17 | Camlog | CONELOG® Titanium Base CAD/CAM | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K143337 |
| K142030 | 2015-01-23 | Cardinal Spine | STGC-Lordotic | MQP | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142030 |
| K142419 | 2014-12-16 | Neoortho Produtos Ortopedicos S/A | Mini and Micro Fragments Reconstruction NEOFIX | HRS, HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142419 |
| K133827 | 2014-11-17 | OsteoVasive | A-Link Z IVB Fusion Device | OVD | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133827 |
| K142090 | 2014-10-29 | Orthorebirth Co., Ltd | ReBOSSIS | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142090 |
| K141103 | 2014-09-23 | Neoortho | Itramedullary Nails and Screws NEONAIL | HSB | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141103 |
| K133991 | 2014-08-06 | Camlog | iSy System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133991 |
| K132881 | 2014-07-03 | Z-Systems | Z5c | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132881 |
| K133327 | 2014-06-25 | Zest Anchors, LLC | Saturno Overdenture Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133327 |
| K141232 | 2014-06-23 | Medartis, AG | APTUS® Ulna Shortening 2.5 | HRS, HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141232 |
| K140570 | 2014-06-16 | Zest Anchors, LLC | Chairside Attachment Processing Material | EBI | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140570 |
| K133018 | 2014-02-26 | Orthopedic Sciences, Inc | OSI Q System Arthoscopes | HRX | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133018 |
| K133696 | 2014-02-25 | Neodent | Neodent Implant System | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133696 |
| K133510 | 2014-02-24 | Neodent | Neodent Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133510 |
| K132792 | 2014-01-31 | Daniels Sharpsmart | Ecoship Disposable Sharps | MMK | General Hospital | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132792 |
| K133460 | 2013-12-18 | Medartis, AG | APTUS® Cannulated Screws 5, 7 | HWC, HTY | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133460 |
| K121177 | 2013-12-05 | Augma Biomaterials | Bond Apatite | LYC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121177 |
| K130999 | 2013-10-25 | Dentsply Implant | OsseoSpeed Profile Ev | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130999 |
| K131701 | 2013-09-05 | Z-Systems | Z5 Mlb Mlc | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K131701 |
| K131345 | 2013-08-07 | Nasseo | TiArray Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K131345 |
| K130787 | 2013-06-13 | Quantum Bioengineering, Ltd. | Quantum™ Dental Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130787 |
| K123022 | 2013-05-17 | Neodent | Neodent Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K123022 |
| K130216 | 2013-05-01 | Dentsply Implant | Atlantis Abutment for Straumann BL | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130216 |
| K122198 | 2013-04-05 | Oco Biomedical | I Macro 6.0mm X 6.0mm Implant | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122198 |
| K123751 | 2013-02-28 | Wellspect Healthcare | LoFric® Sense | EZD | Urology | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K123751 |
| K120038 | 2013-02-14 | Renovis | A200 Knee System | JWH | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120038 |
| K121810 | 2013-01-23 | Astra Tech | OsseoSpeed Angled Ev | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121810 |
| K120793 | 2012-12-21 | Z-Systems | Z-Look3 Evo SLM | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120793 |
| K113779 | 2012-12-14 | Camlog | CONELOG | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113779 |
| K121117 | 2012-12-14 | National Dentex | NDX Custom Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121117 |
| K122078 | 2012-10-31 | Astra Tech | LoFric® PrimoTM and LoFric® Hydro-KitTM | EZD | Urology | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122078 |
| K121176 | 2012-08-17 | Cardinal Spine | STGC | MQP | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121176 |
| K121334 | 2012-08-14 | Thommen Medical, AG | VARIOeco | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121334 |
| K120414 | 2012-07-31 | Astra Tech | OsseoSpeed Plus | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120414 |
| K120176 | 2012-07-25 | Centrix | Senzzzzz Away | LBH | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120176 |
| K112279 | 2012-05-04 | Quantum Bioengineering, Ltd. | Quantum™ Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112279 |
| K120108 | 2012-04-27 | Medartis, AG | APTUS® Proximal Humerus | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120108 |
| K113424 | 2012-04-17 | Astra Tech | LoFric® Pobe Catheter | EZO | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113424 |
| K113733 | 2012-03-23 | Neoortho | Small and Large Fragments Osteosynthesis System NEOFIX | HRS, HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113733 |
| K110404 | 2012-02-16 | Corentec | EAUMTotal Knee System | JWH | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110404 |
| K112046 | 2012-01-06 | Angelus | MTA Angelus | KIF | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112046 |
| K113568 | 2012-01-06 | Angelus | MTA Fillapex | KIF | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113568 |
| K112169 | 2012-01-06 | Medartis, AG | APTUS® Wrist Arthrodesis Plates | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112169 |
| K112560 | 2011-12-15 | Medartis, AG | APTUS® Distal Humerus System | HRS, HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112560 |
| K112857 | 2011-12-13 | Biostructures | Interface Bone Void Filler | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112857 |
| K111944 | 2011-11-22 | Pioneer Surgical Technology | NB3D Bone Void Filler | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111944 |
| K111984 | 2011-11-10 | Thommen Medical, AG | SPI VARIO Angled Abutment | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111984 |
| K110442 | 2011-11-09 | Nanovis | Nanovis Intervertebral Body Fusion System | ODP, MAX | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110442 |
| K111287 | 2011-09-26 | Astra Tech | Astra Tech Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111287 |
| K103431 | 2011-07-21 | Corentec | COREN Total Hip System | LPH | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103431 |
| K110908 | 2011-06-28 | Medartis, AG | APTUS® Foot 3.5 System | HRS, HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110908 |
| K101005 | 2011-06-21 | Astra Tech | Astra Tech Implant System, New Component | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101005 |
| K110658 | 2011-06-02 | Medartis, AG | APTUS® Cannulated Compression Screws | HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110658 |
| K110965 | 2011-05-11 | Renovis | Renovis T 710 Large External Fixation System | KTT | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110965 |
| K110561 | 2011-04-29 | Pioneer Surgical Technology | FortrOss Bone Void Filler | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110561 |
| K102804 | 2011-04-20 | Thommen Medical, AG | SPI Titanium Base For Cad/Cam | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102804 |
| K100698 | 2011-03-14 | Cardinal Spine | STCC | ODP | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K100698 |
| K101732 | 2011-02-23 | Astra Tech | Astra Tech Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101732 |
| K102769 | 2011-02-23 | Neodent | Neodent Implant System | OAT | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102769 |
| K103084 | 2011-02-14 | Neodent | Neodent Implant System | DZL | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103084 |
| K101945 | 2011-01-26 | Neodent | Neodent Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101945 |
| K103332 | 2011-01-24 | Medartis, AG | APTUS® Ulna Plates | HRS, HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103332 |
| K103252 | 2011-01-10 | Camlog | CAMLOG Vario SR Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103252 |
| K102641 | 2010-12-20 | Neoortho | Mini and Micro Fragments Reconstruction System-Neoface | JEY | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102641 |
| K102537 | 2010-12-10 | Medartis, AG | APTUS® 1.5 Trilock | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102537 |
| K092541 | 2010-11-09 | Biostructures | Interface (Extremity, Alone) | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092541 |
| K101426 | 2010-09-15 | Mathys Ltd | Ceros TCP Granules | LYC | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101426 |
| K101798 | 2010-08-19 | Thommen Medical, AG | SPI VARIOmulti Angled Abutment | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101798 |
| K101207 | 2010-08-02 | Neodent | Neodent Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101207 |
| K100361 | 2010-04-22 | Pioneer Surgical Technology | Nanoss Bone Void Filler (Fortross Syringe) | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K100361 |
| K093615 | 2010-03-04 | Thommen Medical, AG | SPI Dental Implant, Element | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K093615 |
| K091031 | 2009-11-17 | Pioneer Surgical Technology | Pioneer Surgical Nanoss BVF-E | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K091031 |
| K092082 | 2009-10-02 | Synergy Surgical Technologies | Synergy Cannulated Screw System | HTN | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092082 |
| K092248 | 2009-09-25 | Thommen Medical, AG | SPI Customizable Gingiva Former | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092248 |
| K092038 | 2009-09-23 | Medartis, AG | APTUS® K-Wire System | HTY | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092038 |
| K091239 | 2009-09-22 | Astra Tech | Astra Tech Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K091239 |
| K090154 | 2009-07-27 | Thommen Medical, AG | SPI Dental Implant Inicell | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090154 |
| K091479 | 2009-07-13 | Medartis, AG | APTUS® Foot System | HRS, HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K091479 |
| K090983 | 2009-07-01 | Medartis, AG | APTUS® 2.0/2.3 Four Corner Fusion Plate | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090983 |
| K090347 | 2009-06-18 | Camlog | CAMLOG Abutments PS | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090347 |
| K090053 | 2009-04-23 | Medartis, AG | APTUS® 2.0 Radial Head System | HRS, HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090053 |
| K090153 | 2009-03-27 | Thommen Medical, AG | SPI VARIOmulti Angled Abutment | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090153 |
| K083858 | 2009-03-17 | Augma Biomaterials | Bond Bone | LYC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083858 |
| K083543 | 2009-03-06 | Denovis | DenovisMed Dental Implant Systems | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083543 |
| K083496 | 2009-01-30 | Camlog | CAMLOG Implant System Modified Implants And Abutments | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083496 |
| K082180 | 2008-12-17 | Angelus | Perma Fiber /Perma Mesh | EBI | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K082180 |
| K081460 | 2008-11-21 | Pou Yu Biotechnology Co, Ltd | TDS Abutment | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081460 |
| K082058 | 2008-10-02 | Cook Biotech, Inc. | DynaMatrix | NPL | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K082058 |
| K080156 | 2008-09-17 | Astra Tech | OsseoSpeed Profile System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K080156 |
| K073685 | 2008-08-29 | Osseous Technology of America | OTA Collagen Biomaterial | NPL | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K073685 |
| K081790 | 2008-07-24 | Trinity Orthopedics, LLC | Modification to SPMA Pedicle Screw System | MNI, MNH | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081790 |
| K081157 | 2008-07-22 | Cagenix | Accuframe | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081157 |
| K071074 | 2008-07-02 | Showa Ika Kohgyo Co.,Ltd. | MYKRES Spinal System | KWP, KWQ, MNH | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071074 |
| K080396 | 2008-04-30 | Astra Tech | OsseoSpeed Narrow | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K080396 |
| K073553 | 2008-03-05 | Camlog | CAMLOG Implant System Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K073553 |
| K072856 | 2008-02-15 | Thommen Medical, AG | SPI VARIOmulti Abutment | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072856 |
| K072649 | 2007-12-06 | Thommen Medical, AG | SPI System Dental Implants | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072649 |
| K073141 | 2007-12-05 | Thommen Medical, AG | SPI Art Abutment | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K073141 |
| K073054 | 2007-11-27 | Cayenne Medical, Inc. | Modification To AperFix Femoral Implant With Inserter | HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K073054 |
| K072933 | 2007-11-15 | Thommen Medical, AG | SPI Contact Platform O 4.0 Mm | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072933 |
| K062542 | 2007-10-29 | Z-Systems | Z-Look3 Dental Implant System, Model Z3-XXX | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K062542 |
| K071070 | 2007-10-23 | Keystone | Olympus Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071070 |
| K071796 | 2007-10-19 | Cayenne Medical, Inc. | Capsew Plication System | GAT | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071796 |
| K071638 | 2007-10-10 | BioHorizons | BioHorizons Tapered Internal Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071638 |
| K072624 | 2007-10-01 | Astra Tech | Astra Tech Implant System, New Component | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072624 |
| K071453 | 2007-09-19 | Thommen Medical, AG | SPI EASY 4.0 Abutment | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071453 |
| K071612 | 2007-09-11 | Medartis, AG | MODUS Trilock 2.0/2.3/2.5 | JEY | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071612 |
| K071213 | 2007-08-10 | Camlog | CAMLOG Logfit Prosthetic System | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071213 |
| K071500 | 2007-08-10 | Pentron | Nano-Bond II Adhesive System | KLE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071500 |
| K071743 | 2007-07-06 | 4th Column | Pillar Pedicle Screw System | MNI, MNH | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071743 |
| K070295 | 2007-05-21 | Trinity Orthopedics, LLC | Single Planar Multi Axial (SPMA) Pedicle Screw System | MNI, MNH | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070295 |
| K063779 | 2007-04-27 | Astra Tech | OsseoSpeed 4.0s-6mm, Model 24619 | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K063779 |
| K070290 | 2007-04-17 | Thommen Medical, AG | SPI VECTODRILL Ceramic Drills | NDP | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070290 |
| K063205 | 2007-02-26 | Atlas Spine LLC | Atlas Spine Vertebral Body Replacement | MQP | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K063205 |
| K063794 | 2007-01-24 | LDR Spine USA | Modification to Easyspine System | MNI, MNH | Opthalmic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K063794 |
| K070007 | 2007-01-10 | Thommen Medical, AG | SPI ELEMENT Platform O 4.0 Mm | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070007 |
| K061578 | 2006-12-26 | Specialty Spine Products, LLC | SSP Vertebral Body Replacement | MQP | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061578 |
| K063070 | 2006-12-14 | Cayenne Medical, Inc. | AperFix Tibial Implant With Inserter | HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K063070 |
| K062487 | 2006-11-17 | Cayenne Medical, Inc. | AperFix Femoral Implant With Inserter | HWZ | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K062487 |
| K061410 | 2006-09-08 | Zimmer Dental Inc. | Screw-Vent Implant System, Sv;Tapered Screw -Vent Implant System, Tsv;Advent Implant System,Av;Zimmer One-Piece Implant | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061410 |
| K061335 | 2006-08-09 | Coastal Biocare | Enhance Dental Implant System | DZE, NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061335 |
| K061266 | 2006-07-31 | Ortho Organizers, Inc. | Ortho Organizers Temporary Orthodontic Anchor | OAT | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061266 |
| K061807 | 2006-07-31 | Thommen Medical, AG | SPI Art Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061807 |
| K051704 | 2006-07-03 | Showa Ika Kohgyo Co.,Ltd. | MYKRES Spinal System | KWP, MNH | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051704 |
| K060118 | 2006-06-08 | Specialty Spine Products, LLC | SSP Pedicle Screw System | MNI, MNH | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K060118 |
| K053384 | 2006-03-24 | Astra Tech | Fixture MicroThread OsseoSpeed | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K053384 |
| K052847 | 2005-12-12 | X-Spine Systems, Inc. | Capless Pedicle Screw System | MNI, MNH | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K052847 |
| K052061 | 2005-10-21 | Medartis, Inc. | MODUS IMF Screws 2.0 | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K052061 |
| K051859 | 2005-09-23 | S.I.N. – Sistema De Implante Nacional Ltda | Sistema De Implante Nacional (S.I.N.); Dental Implant System | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051859 |
| K051567 | 2005-08-23 | Medartis, Inc. | APTUS® Titanium Osteosynthesis System | HRS | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051567 |
| K051946 | 2005-08-22 | Medartis, Inc. | MODUS Modular Distraction Osteogenesis System | MQN | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051946 |
| K051527 | 2005-07-28 | Thommen Medical, AG | SPI EASY Temporary Cap | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051527 |
| K051502 | 2005-06-21 | Thommen Medical, AG | SPI Dental Implant | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051502 |
| K050789 | 2005-05-27 | R And D Medical, Llc | Formagraft Collagen Bone Graft Matrix | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050789 |
| K050934 | 2005-05-05 | Medartis, Inc. | MODUS Titanium Osteosynthesis System | JEY | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050934 |
| K042715 | 2005-03-23 | Titan Implants, Inc. | Titan Dental Implant Attachment | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K042715 |
| K050025 | 2005-02-03 | Angstrom Medica, Inc. | Nanoss Bone Void Filler | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050025 |
| K042971 | 2005-01-14 | Titan Implants, Inc. | Titan Dental Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K042971 |
| K040493 | 2004-09-03 | Orthopedic Sciences, Inc | Outologous Spinal Fixation System | MNI, MNH | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K040493 |
| K040850 | 2004-06-24 | Orthopedic Sciences, Inc | TSY Shoulder Plate Implant | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K040850 |
| K033699 | 2004-04-22 | Zest Anchors, LLC | Locator Bar Female, Locator Laser Bar Female, Locator Bar Cast-To Female, Models 08587, 08588, 08586 | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K033699 |
| K034014 | 2004-03-05 | Thommen Medical, AG | SPI CONTACT Dental Implant | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K034014 |
| K033346 | 2003-11-03 | Thommen Medical, AG | SPI EASYDental Implant Protective Cap | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K033346 |
| K031319 | 2003-07-17 | Aspine USA, Inc. | Osteo-G Bone Void Filler System | MQV | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K031319 |
| K031747 | 2003-07-02 | Thommen Medical, AG | SPI Dental Implant Abutments | NHA | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K031747 |
| K030689 | 2003-03-26 | Thommen Medical, AG | SPI ELEMENT Dental Implant O 3.5 Mm | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K030689 |
| K023645 | 2002-11-13 | Thommen Medical, AG | SPI EASY Dental Implant Abutment | NHA, DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K023645 |
| K022139 | 2002-09-23 | Orthopedic Sciences, Inc | Hip Tool Implant | HRS | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K022139 |
| K022038 | 2002-07-15 | PaxMed International | SPI ONETIME Dental Implant | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K022038 |
| K020554 | 2002-05-03 | Kinetikos Medical, Inc. | Modification to Universal Total Wrist System | JWJ | Opthalmic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K020554 |
| K000035 | 2001-09-28 | Omnicare Dental Implant Center | Omnicare Dental Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K000035 |
| K010467 | 2001-09-28 | PaxMed International | Universal Dental Coping (UDC) | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K010467 |
| K011574 | 2001-09-28 | Universal Implant Systems, Inc. | Uniplant Dental Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K011574 |
| K002241 | 2001-09-20 | Quantum Bioengineering, Ltd. | Quantum Versatility (QVS) Dental Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K002241 |
| K011223 | 2001-09-20 | Quantum Bioengineering, Ltd. | Quantum Versatility (QVS) Dental Implant System | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K011223 |
| K003338 | 2001-02-07 | Integrated Orbital Implants, Inc. | Bio-Eye II Orbital Implant | HPZ, MTZ | Opthalmic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K003338 |
| K994158 | 2000-07-24 | MacroPore Biosurgery, Inc. | MacroSorbOS Protective Sheet | HRS, HWC, MAI | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K994158 |
| K001337 | 2000-07-05 | The Daniels Corp. | Daniels Sharpsmart Reusable Sharps Container | MHK | General Hospital | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001337 |
| K000151 | 2000-04-10 | Integrated Orbital Implants, Inc. | Perry-Kolberg (PK) Ha-Coated Titanium Sleeve | MQU | Opthalmic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K000151 |
| K983120 | 1999-07-29 | Oraltronics Marketing-Und Vertriebs Gmbh | Bicortical Screw | DZE | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K983120 |
| K983360 | 1999-03-19 | Pacific Materials and Interfaces | MacroPore Protective Sheet | JEY | Dental | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K983360 |
| K972913 | 1998-07-30 | Pacific Materials and Interfaces | MacroPore Protective Sheet (Protego System) | HRS, HWC | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K972913 |
| K980609 | 1998-05-18 | Metagen, LLC | Segmental Defect Replacement System | HSB | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K980609 |
| K980020 | 1998-04-03 | Metagen, LLC | ActiveLock Modular Femoral Hip System | LPH, JDI, MEH | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K980020 |
| K974203 | 1998-02-04 | Integrated Orbital Implants, Inc. | Perry-Kolberg (PK) Titanium Motility/Support System | MQU | Opthalmic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K974203 |
| K972327 | 1997-08-11 | Pacific Materials and Interfaces | Metagen ActiveLock Cerclage System | JDQ | Orthopedic | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K972327 |