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 |
|---|---|---|---|
| 10886982350602 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350619 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350626 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350695 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350701 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350718 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350596 | VOLT | Synthes GmbH | 2026-09-25 |
| 03701313009502 | K-ROD | S.M.A.I.O | 2026-09-22 |
| 00840606191326 | Primus | SPINAL ELEMENTS, INC. | 2026-09-22 |
| 10888857298644 | ALEUTIAN® Interbody Systems | VB Spine LLC | 2024-05-16 |
| 10888857298637 | ALEUTIAN® Interbody Systems | VB Spine LLC | 2024-05-16 |
| 10888857298651 | ALEUTIAN® Interbody Systems | VB Spine LLC | 2024-05-16 |
| 10888857298620 | ALEUTIAN® Interbody Systems | VB Spine LLC | 2024-05-16 |
| 10888857298613 | ALEUTIAN® Interbody Systems | VB Spine LLC | 2024-05-16 |
| 10888857298606 | ALEUTIAN® Interbody Systems | VB Spine LLC | 2024-05-16 |
| 10888857298590 | ALEUTIAN® Interbody Systems | VB Spine LLC | 2024-05-16 |
| 10888857298668 | ALEUTIAN® Interbody Systems | VB Spine LLC | 2024-05-16 |
| 00643169860957 | Medtronic Resuable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-11-14 |
| 00643169860940 | Medtronic Resuable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-11-14 |
| 00885074527918 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-07 |
| 00885074527901 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-07 |
| 00885074527895 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-07 |
| 00885074527871 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-07 |
| 00885074527864 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-07 |
| 00885074527857 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-07 |
| 07613327262452 | XIA | Stryker Corporation | 2019-11-22 |
| 07613327262230 | XIA | Stryker Corporation | 2019-11-08 |
| 07613327264463 | XIA 4.5 | Stryker Corporation | 2019-11-08 |
| 00888118108364 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | 2018-09-26 |
| 00888118108357 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | 2018-09-26 |