Product code HWR
- Device name
- Driver, Prosthesis
- 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 |
|---|---|---|---|
| K915776 | KNEE PROSTHESIS DRIVER | Kim-Med, Inc. | 1992-06-11 |
| K875054 | ACROMED ADS BONE NAIL DRIVER | Buckman Co., Inc. | 1988-01-28 |
| K870847 | SCHULTZ PHALANGEAL COMPONENT DRIVER | Warsaw Orthopedic, Inc. | 1987-03-13 |
| K870848 | SCHULTZ METACARPAL COMPONENT DRIVER | Warsaw Orthopedic, Inc. | 1987-03-13 |
Related GUDID Devices#
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|---|---|---|---|
| 08809926260312 | InnoOrtho | innoOrtho Co., Ltd. | 2026-06-01 |
| 08809926260299 | InnoOrtho | innoOrtho Co., Ltd. | 2026-06-01 |
| 08809926260404 | InnoOrtho | innoOrtho Co., Ltd. | 2026-06-01 |
| 08809926260398 | InnoOrtho | innoOrtho Co., Ltd. | 2026-06-01 |
| 08809926260381 | InnoOrtho | innoOrtho Co., Ltd. | 2026-06-01 |
| 08809926260374 | InnoOrtho | innoOrtho Co., Ltd. | 2026-06-01 |
| 08809926260367 | InnoOrtho | innoOrtho Co., Ltd. | 2026-06-01 |
| 08809926260350 | InnoOrtho | innoOrtho Co., Ltd. | 2026-06-01 |
| 08809926260343 | InnoOrtho | innoOrtho Co., Ltd. | 2026-06-01 |
| 08809926260336 | InnoOrtho | innoOrtho Co., Ltd. | 2026-06-01 |
| 08809926260329 | InnoOrtho | innoOrtho Co., Ltd. | 2026-06-01 |
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| 00190446356820 | DJO SURGICAL | Encore Medical, L.P. | 2021-02-12 |
| 10603295094869 | NA | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |
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| 10603295171904 | S-ROM | DEPUY (IRELAND) | 2018-09-24 |
| 10603295171911 | S-ROM | DEPUY (IRELAND) | 2018-09-24 |
| 10603295171928 | S-ROM | DEPUY (IRELAND) | 2018-09-24 |
| 10603295171935 | S-ROM | DEPUY (IRELAND) | 2018-09-24 |
| 10603295171942 | S-ROM | DEPUY (IRELAND) | 2018-09-24 |
| 10603295171959 | S-ROM | DEPUY (IRELAND) | 2018-09-24 |
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| 10381780247562 | Ti6® Internal Fixation System | Ascension Orthopedics, Inc. | 2017-09-05 |
| 00889024310810 | NEXGEN® | ZIMMER TRABECULAR METAL TECHNOLOGY INC. | 2016-06-20 |