Product code GFJ
- Device name
- Mallet, Surgical, General & Plastic Surgery
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- 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 |
|---|---|---|---|
| G586NS46317910 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| 07898506847563 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
| 07898506813490 | Quinelato | Schobell Industrial Ltda | 2022-12-08 |
| 10603295178439 | NA | DEPUY (IRELAND) | 2018-09-24 |
| 10603295182382 | NA | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |
| 10603295123064 | MORELAND | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |
| 10603295120902 | NA | DEPUY (IRELAND) | 2018-09-24 |
| 10603295108290 | NA | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |
| 10603295108283 | NA | DEPUY (IRELAND) | 2018-09-24 |
| 10603295108276 | NA | DEPUY (IRELAND) | 2018-09-24 |
| 10649111302220 | Sklar® | SKLAR CORPORATION | 2018-08-09 |
| 10649111302336 | Sklar® | SKLAR CORPORATION | 2018-08-09 |
| 10649111302534 | Sklar® | SKLAR CORPORATION | 2018-08-09 |
| 10649111302992 | Sklar® | SKLAR CORPORATION | 2018-08-09 |
| 10649111320538 | Sklar® | SKLAR CORPORATION | 2018-08-07 |
| 10649111320200 | Sklar® | SKLAR CORPORATION | 2018-08-07 |
| 10649111319686 | Sklar® | SKLAR CORPORATION | 2018-08-07 |
| 10649111319402 | Sklar® | SKLAR CORPORATION | 2018-08-07 |
| 10649111319143 | Sklar® | SKLAR CORPORATION | 2018-08-07 |
| 10649111318856 | Sklar® | SKLAR CORPORATION | 2018-08-07 |
| 10649111318559 | Sklar® | SKLAR CORPORATION | 2018-08-07 |
| 10649111317859 | Sklar® | SKLAR CORPORATION | 2018-08-07 |
| 10649111317231 | Sklar® | SKLAR CORPORATION | 2018-08-07 |
| 10381780215646 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780456476 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780456483 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780457268 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780100744 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-10 |
| 10381780427155 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-10 |
| 10381780427162 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-10 |