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 |
|---|---|---|---|
| 18257200103591 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103959 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103942 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103935 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103867 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103850 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103843 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103836 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103829 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103812 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103805 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103799 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103782 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103614 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103607 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103096 | ALLOGRAFT - CORTICAL | Orthofix US LLC | 2026-07-17 |
| 18257200103584 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103577 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103560 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103553 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103546 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103539 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103522 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103164 | ALLOGRAFT - CORTICAL | Orthofix US LLC | 2026-07-17 |
| 18257200103157 | ALLOGRAFT - CORTICAL | Orthofix US LLC | 2026-07-17 |
| 18257200103140 | ALLOGRAFT - CORTICAL | Orthofix US LLC | 2026-07-17 |
| 18257200103133 | ALLOGRAFT - CORTICAL | Orthofix US LLC | 2026-07-17 |
| 18257200103126 | ALLOGRAFT - CORTICAL | Orthofix US LLC | 2026-07-17 |
| 18257200103119 | ALLOGRAFT - CORTICAL | Orthofix US LLC | 2026-07-17 |
| 18257200103102 | ALLOGRAFT - CORTICAL | Orthofix US LLC | 2026-07-17 |