Product code HXC
- Device name
- Wrench
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- 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 |
|---|---|---|---|
| K180092 | Intellitorq | Gauthier Biomedical, Inc. | 2018-03-08 |
| K874358 | COMBINATION WRENCHES | Med-Tool, Inc. | 1987-11-23 |
| K874359 | ADJUSTABLE WRENCHES | Med-Tool, Inc. | 1987-11-23 |
| K870053 | TORQUEDRIVER WRENCH | Jerome Medical | 1987-03-11 |
| K813067 | SPINAL WRENCH | Twin City Surgical, Inc. | 1981-11-24 |
| K791073 | WRENCH | Truth, Inc. | 1979-06-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B756007053001000 | Torque Wrench | Shukla Medical | 2026-06-01 |
| 08059386742273 | Orthopaedic Surgical Instruments | CITIEFFE SRL | 2025-11-05 |
| 00841732144309 | GENERIC Surgical Instruments | CTL Medical Corporation | 2023-09-15 |
| 08800068966230 | LOSPA Modular Knee System | Corentec Co., Ltd | 2022-10-24 |
| 08800068964960 | LOSPA Modular Knee System | Corentec Co., Ltd | 2022-10-23 |
| 08809265159063 | Surgical Instrument | Jeil Medical Corporation | 2018-11-28 |
| 08809265159070 | Surgical Instrument | Jeil Medical Corporation | 2018-11-28 |
| 10603295216759 | P.F.C. | DEPUY (IRELAND) | 2018-09-24 |
| 10603295172659 | S-ROM | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |
| 10603295155898 | RECLAIM | DEPUY (IRELAND) | 2018-09-24 |
| 10603295147299 | S-ROM | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |
| 10603295123156 | MORELAND | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |
| 10603295098997 | PINNACLE | DEPUY (IRELAND) | 2018-09-24 |
| 10603295097846 | PINNACLE GRIPTION TF | DEPUY (IRELAND) | 2018-09-24 |
| 10603295097204 | PINNACLE | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |
| 08033390113816 | Revision Femoral Stems | LIMACORPORATE SPA | 2018-09-21 |
| 08033390098007 | SMR Shoulder system | LIMACORPORATE SPA | 2018-09-21 |
| 08033390085946 | SMR Shoulder system | LIMACORPORATE SPA | 2018-09-21 |
| 08033390027694 | Revision Femoral Stems | LIMACORPORATE SPA | 2018-09-21 |
| 08033390027649 | SMR Shoulder system | LIMACORPORATE SPA | 2018-09-21 |
| 10603295116394 | GLOBAL UNITE | DEPUY (IRELAND) | 2018-06-15 |
| 10381780251118 | Integra® External Fixation System | Ascension Orthopedics, Inc. | 2018-04-13 |
| 10381780248231 | Integra® | Ascension Orthopedics, Inc. | 2017-09-05 |
| 10381780248057 | Integra® | Ascension Orthopedics, Inc. | 2017-08-30 |
| 10381780248064 | Integra® | Ascension Orthopedics, Inc. | 2017-08-30 |
| 10381780248071 | Integra® | Ascension Orthopedics, Inc. | 2017-08-30 |
| 10381780248088 | Integra® | Ascension Orthopedics, Inc. | 2017-08-30 |
| 08033201842300 | ILIZAROV SYSTEMS | MEDICALPLASTIC SRL | 2016-10-07 |
| 08033201842294 | ILIZAROV SYSTEMS | MEDICALPLASTIC SRL | 2016-09-30 |
| 08033201842034 | ILIZAROV SYSTEMS | MEDICALPLASTIC SRL | 2016-09-30 |