Product code FZY
- Device name
- Hammer, Surgical
- 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#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K802524 | SURGICAL HAMMERS | Midshore Welding Corp. | 1980-11-12 |
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| 10649111335396 | Sklar | SKLAR CORPORATION | 2019-07-30 |
| 10649111322648 | Sklar | SKLAR CORPORATION | 2019-07-30 |
| 10603295122906 | NA | DEPUY (IRELAND) | 2018-09-24 |
| 10603295248620 | SPECIALIST | DEPUY (IRELAND) | 2018-09-24 |
| 10603295208501 | P.F.C. ULTIMA | DEPUY (IRELAND) | 2018-09-24 |
| 10603295159155 | LPS | DEPUY (IRELAND) | 2018-09-24 |
| 10381780458494 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-02 |
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| 00841132135396 | PediNail | ORTHOPEDIATRICS CORP. | 2017-02-15 |
| 10705034212623 | LEOPARD | DEPUY SPINE, LLC | 2016-12-31 |
| 10705034217222 | CONCORDE | DEPUY SPINE, LLC | 2016-12-31 |
| 10705034220116 | CONCORDE | DEPUY SPINE, LLC | 2016-12-31 |
| 10705034188706 | BENGAL | DEPUY SPINE, LLC | 2016-11-18 |