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 |
|---|---|---|---|
| 00810022403440 | LinkBio Instrument | Link Bio Corp | 2026-06-08 |
| 00810022403457 | LinkBio Instrument | Link Bio Corp | 2026-06-08 |
| 00810022403433 | LinkBio Instrument | Link Bio Corp | 2026-06-08 |
| 04048844770976 | n/a | implantcast GmbH | 2026-06-02 |
| 04048844770952 | n/a | implantcast GmbH | 2026-06-02 |
| 04048844770938 | n/a | implantcast GmbH | 2026-06-02 |
| 04048844770891 | n/a | implantcast GmbH | 2026-06-02 |
| 04048844770808 | n/a | implantcast GmbH | 2026-06-02 |
| 04048844770747 | n/a | implantcast GmbH | 2026-06-02 |
| 04048844758820 | n/a | implantcast GmbH | 2026-06-02 |
| 04048844758776 | n/a | implantcast GmbH | 2026-06-02 |
| 04048844758295 | EPORE® XO | implantcast GmbH | 2026-06-02 |
| 04048844758271 | EPORE® XO | implantcast GmbH | 2026-06-02 |
| 04048844758233 | EPORE® XO | implantcast GmbH | 2026-06-02 |
| 04048844758219 | EPORE® XO | implantcast GmbH | 2026-06-02 |
| 04048844758950 | n/a | implantcast GmbH | 2026-06-02 |
| 00850011453544 | REMEDY CoCr Modular Heads | OSTEOREMEDIES, LLC | 2026-06-01 |
| 10603295555018 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-05-29 |
| 10603295555582 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-05-29 |
| 10603295555544 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-05-29 |
| 10603295555056 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-05-29 |
| 10603295555049 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-05-29 |
| 10603295555032 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-05-29 |
| 10603295555025 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-05-29 |
| 10603295555001 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-05-29 |
| 10603295552680 | ATTUNE | DEPUY ORTHOPAEDICS, INC. | 2026-05-29 |
| 10885862660527 | AcuMatch | Exactech, Inc. | 2026-05-28 |
| 10885862660541 | AcuMatch | Exactech, Inc. | 2026-05-28 |
| 10885862660558 | AcuMatch | Exactech, Inc. | 2026-05-28 |
| 10885862660565 | AcuMatch | Exactech, Inc. | 2026-05-28 |