Product code HWA
- Device name
- Impactor
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03701089527941 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527958 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089528450 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089547512 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527934 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 18257200103188 | ALLOGRAFT - CORTICAL,CONSTRUX - MINI PEEK VBR | Orthofix US LLC | 2026-07-17 |
| 18257200103881 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 18257200103898 | ALLOQUENT - ALIF | Orthofix US LLC | 2026-07-17 |
| 00822409135721 | N/A | Ortho Development Corporation | 2026-07-16 |
| 07630055307781 | Positioning handle - M8x1 interface | Incipio Devices SA | 2026-07-16 |
| 07630055307798 | Positioning handle - M10x1.5 interface | Incipio Devices SA | 2026-07-16 |
| 07630055307804 | Offset Cup Impactor - M8x1 interface | Incipio Devices SA | 2026-07-16 |
| 07630055307811 | Offset Cup Impactor - M10x1.5 interface | Incipio Devices SA | 2026-07-16 |
| 00840286860406 | Tahoe Unicompartmental Knee System | Shalby Advanced Technologies, Inc. | 2026-07-09 |
| 00885556925690 | NA | Smith & Nephew, Inc. | 2026-06-04 |
| 08809885739751 | PYXIS 3D Titanium Cervical Cage, Close | GS Medical Co., Ltd. | 2026-01-28 |
| 00841732162709 | GENERIC Surgical Instruments | CTL Medical Corporation | 2023-09-27 |
| 00841732162716 | GENERIC Surgical Instruments | CTL Medical Corporation | 2023-09-27 |
| 07613327538601 | INSTRUMENT | Howmedica Osteonics Corp. | 2023-06-30 |
| 07630055302458 | Offset Cup Impactor - M8x1 interface | Incipio Devices SA | 2020-04-23 |
| 07630055302465 | Offset Cup Impactor - M10x1.5 interface | Incipio Devices SA | 2020-04-23 |
| 07640178983052 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-02-01 |
| 10381780045946 | SOLUSTAPLE® | NEWDEAL | 2017-05-26 |
| 10381780045939 | LARGE UNI-CLIP® | NEWDEAL | 2017-05-26 |
| 10381780045953 | SOLUSTAPLE® | NEWDEAL | 2017-05-26 |
| 10381780045922 | LARGE UNI-CLIP® | NEWDEAL | 2017-05-26 |
| 10381780045915 | FOREFOOT SOLUTIONS™ | NEWDEAL | 2017-05-26 |
| 10886982198433 | NA | Synthes GmbH | 2016-12-31 |
| 10705034777375 | NA | Synthes GmbH | 2016-12-31 |
| 10705034775401 | NA | Synthes GmbH | 2016-12-31 |