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 |
|---|---|---|---|
| 10705034579924 | N/A | Medos International Sàrl | 2026-08-26 |
| 10705034579917 | N/A | Medos International Sàrl | 2026-08-26 |
| 10705034579900 | N/A | Medos International Sàrl | 2026-08-26 |
| 10603295553618 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-08-26 |
| 10603295553601 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-08-26 |
| 10603295553588 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-08-26 |
| 10603295553595 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-08-26 |
| 00889024713291 | Left Uni Knee Tensor | Zimmer, Inc. | 2026-08-25 |
| 00889024713284 | Right Uni Knee Tensor | Zimmer, Inc. | 2026-08-25 |
| 00889024713277 | Universal Uni Knee Tensor | Zimmer, Inc. | 2026-08-25 |
| 00889024711464 | Comp Mini Humeral Tray Trial Stem Adapter | Zimmer, Inc. | 2026-08-25 |
| 00860009784925 | Flap Marking Template | Mirrorme3d, LLC | 2023-03-17 |
| 00860009784918 | Template | Mirrorme3d, LLC | 2023-02-16 |
| 00196852129638 | Template | Mirrorme3d, LLC | 2022-10-03 |
| 10885862012197 | AcuMatch | Exactech, Inc. | 2022-09-19 |
| 10885862135667 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862012173 | AcuMatch | Exactech, Inc. | 2022-09-19 |
| 10885862011176 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862011145 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862011091 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862011084 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862011077 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862011060 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862135049 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862135056 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862135063 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862135070 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862135636 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862135643 | NA | Exactech, Inc. | 2022-09-19 |
| 10885862135650 | NA | Exactech, Inc. | 2022-09-19 |