Product code HWT
- Device name
- Template
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4800
- Review panel
- OR
- Implant
- N
- 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 |
|---|---|---|---|
| K974406 | ORTHOPLAN | Ortho-Graphics, Inc. | 1998-02-18 |
| K960685 | ORTHODOC PREOPERATIVE PLANNER MODEL 500 | Integrated Surgical Systems, Inc. | 1997-01-17 |
| K894228 | KRONNER SPHERICAL CUTTERS | Kronner Medical | 1990-07-23 |
| K870843 | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | Warsaw Orthopedic, Inc. | 1987-05-27 |
| K871323 | ARTHROSCOPIC MENISCAL SUTURE SYSTEM | Orthopedic Systems, Inc. | 1987-05-01 |
| K830360 | 3M OSTEOTOMY GUIDE | 3M Company | 1983-03-01 |
| K811205 | MOLDED POLYSULFONE TRIAL PROSTHESIS | Shannon Group | 1981-05-21 |
| K781091 | KNEE INSTRUMENTATION, CONDYLAR | Biomet, Inc. | 1978-07-17 |
| K771709 | WORRELL TRIAL PATELLA | Depuy, Inc. | 1977-10-06 |
| K771710 | WORRELL PATELLA TEMPLATE | Depuy, Inc. | 1977-10-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556828168 | Movement Great Toe System | Smith & Nephew, Inc. | 2023-02-02 |
| 00885556834381 | Silicone Toe System | Smith & Nephew, Inc. | 2022-12-22 |
| 00885556833940 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-22 |
| 00885556833933 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-22 |
| 00885556834541 | Silicone Toe System | Smith & Nephew, Inc. | 2022-12-22 |
| 00885556834428 | Silicone Toe System | Smith & Nephew, Inc. | 2022-12-22 |
| 00885556834404 | Silicone Toe System | Smith & Nephew, Inc. | 2022-12-22 |
| 00885556826379 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826355 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826362 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826416 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826386 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826393 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826348 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826409 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826652 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826645 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826638 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826454 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826447 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826423 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00812998034697 | 4WEB Medical | 4web Medical | 2018-12-14 |
| 00812998034703 | 4WEB Medical | 4web Medical | 2018-12-14 |
| 00812998034710 | 4WEB Medical | 4web Medical | 2018-12-14 |
| 00812998034727 | 4WEB Medical | 4web Medical | 2018-12-14 |
| 00812998034734 | 4WEB Medical | 4web Medical | 2018-12-14 |
| 00812998034741 | 4WEB Medical | 4web Medical | 2018-12-14 |
| 00812998034758 | 4WEB Medical | 4web Medical | 2018-12-14 |
| 00812998034765 | 4WEB Medical | 4web Medical | 2018-12-14 |
| 00812998035854 | 4WEB Medical | 4web Medical | 2018-12-14 |