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 |
|---|---|---|---|
| 00190776423582 | Millennium | Avalign Technologies, Inc. | 2026-08-07 |
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| 00840314269744 | gSource | GSOURCE LLC | 2025-05-05 |
| B7687710420 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2025-03-27 |
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| G586NS46317910 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| B7687648060 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2024-01-26 |
| B7685685210 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-10-20 |
| B7687710700 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-04-21 |
| B7684830010 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-04-10 |
| B7682459190 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2022-12-19 |
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| 10603295178439 | NA | DEPUY (IRELAND) | 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 |
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| 10381780100744 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-10 |