Product code JDS
- Device name
- Nail, Fixation, Bone
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | 2025-06-12 |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | Smith & Nephew, Inc. | 2024-09-20 |
| K241804 | TRIGEN INTERTAN 10S Nail System | Smith & Nephew, Inc. | 2024-08-22 |
| K233150 | NET BRAND Osteosynthesis Nailing System | Narang Medical , Ltd. | 2024-02-20 |
| K230761 | TRIGEN META-NAIL Nail System | Smith & Nephew, Inc. | 2023-06-14 |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm | Synthes (USA) Products, LLC | 2020-09-03 |
| K192003 | Auxein Nailing System | Auxein Medical Private Limited | 2020-06-10 |
| K193533 | WIN Flexible Nail System | Biomet, Inc. | 2020-02-20 |
| K141737 | CONVENTUS PHS SYSTEM | Conventus Orthopaedics, Inc. | 2015-04-08 |
| K123948 | CHINA NAILS AND ACCESSORIES | Smith & Nephew, Inc. | 2013-03-14 |
| K111667 | SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS | Synthes (Usa) | 2011-12-05 |
| K080706 | CONNEXX LOCKING TIBIA NAIL | I.T.S. Implantat-Technologie-Systeme GmbH | 2008-06-09 |
| K072095 | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS | Synthes (Usa) | 2007-09-27 |
| K062872 | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM | Synthes (Usa) | 2007-03-13 |
| K061783 | KNEE FUSION NAIL | Smith & Nephew, Inc. | 2006-08-10 |
| K061019 | TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS | Smith & Nephew, Inc. | 2006-06-06 |
| K051557 | TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS | Smith & Nephew, Inc. | 2005-06-30 |
| K050938 | KNEE FUSION NAIL | Smith & Nephew, Inc. | 2005-05-04 |
| K040762 | SYNTHES (USA) TIBIAL NAIL SYSTEM EX | Synthes (Usa) | 2004-04-12 |
| K040212 | TRIGEN INTERTAN | Smith & Nephew, Inc. | 2004-02-20 |
| K033071 | SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM | Synthes (Usa) | 2003-11-05 |
| K032634 | NORMED COMPRESSION BONE SCREW SYSTEM | Noviace Corporation | 2003-10-06 |
| K021782 | BNF | Aap Implantate AG | 2002-08-26 |
| K014189 | ODI TALON INTRAMEDULLARY HIP NAIL | Orthopedic Designs, Inc. | 2002-03-21 |
| K011504 | BAUMER LOCKING NAIL | Baumer, S.A | 2001-08-14 |
| K003212 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) | Disco-O-Tech Medical Technologies, Ltd. | 2000-12-28 |
| K003215 | MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) | Disco-O-Tech Medical Technologies, Ltd. | 2000-12-27 |
| K002325 | WUJIN #3 TIBIAL NAIL | Biologically Oriented Prostheses | 2000-10-30 |
| K002729 | SYNTHES PROXIMAL HUMERAL NAIL | Synthes (Usa) | 2000-10-06 |
| K000764 | PEDIATRIC FIXATION RODS | Biomet, Inc. | 2000-04-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08905892004674 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004773 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004766 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004759 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004742 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004735 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004728 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004711 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004704 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004698 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004681 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004667 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004650 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004643 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004636 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004629 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004612 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004605 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004599 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004780 | GPC | GPC MEDICAL LIMITED | 2024-01-31 |
| 08905892004575 | GPC | GPC MEDICAL LIMITED | 2023-12-30 |
| 08905892004568 | GPC | GPC MEDICAL LIMITED | 2023-12-30 |
| 08905892006968 | GPC | GPC MEDICAL LIMITED | 2023-11-30 |
| 08905892006975 | GPC | GPC MEDICAL LIMITED | 2023-11-30 |
| 08905892006982 | GPC | GPC MEDICAL LIMITED | 2023-11-30 |
| 08905892006999 | GPC | GPC MEDICAL LIMITED | 2023-11-30 |
| 08905892007002 | GPC | GPC MEDICAL LIMITED | 2023-11-30 |
| 08905892007019 | GPC | GPC MEDICAL LIMITED | 2023-11-30 |
| 08905892007026 | GPC | GPC MEDICAL LIMITED | 2023-11-30 |
| 08905892007033 | GPC | GPC MEDICAL LIMITED | 2023-11-30 |