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 |
|---|---|---|---|
| 00889795150073 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00810129551846 | OvertureTi | Overture Resurfacing Inc | 2025-07-23 |
| 00810112596991 | MOTOBAND Instruments | CROSSROADS EXTREMITY SYSTEMS | 2024-08-01 |
| 00810112596960 | MOTOBAND Instruments | CROSSROADS EXTREMITY SYSTEMS | 2024-08-01 |
| 00810112596953 | MOTOBAND Instruments | CROSSROADS EXTREMITY SYSTEMS | 2024-08-01 |
| 00810112596946 | MOTOBAND Instruments | CROSSROADS EXTREMITY SYSTEMS | 2024-08-01 |
| 00810112596939 | MOTOBAND Instruments | CROSSROADS EXTREMITY SYSTEMS | 2024-08-01 |
| 00810112596922 | MOTOBAND Instruments | CROSSROADS EXTREMITY SYSTEMS | 2024-08-01 |
| 00810112596243 | MOTOBAND Instruments | CROSSROADS EXTREMITY SYSTEMS | 2024-08-01 |
| 00810129551372 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129551419 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129551402 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129551396 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129551365 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129551358 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129551273 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129551266 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129551242 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129551143 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129551105 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129551068 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129550894 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129550887 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129550863 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129550818 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129550771 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| 00810129550733 | OvertureTi | Overture Resurfacing Inc | 2023-10-25 |
| B562EFTEMPS080 | WishFIX | Wishbone Medical, Inc. | 2021-11-22 |
| B562EFTEMPS08US0 | WishFIX | Wishbone Medical, Inc. | 2021-11-22 |
| 00643169328716 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | 2017-12-09 |