Panels › General, Plastic Surgery › Product code GFG · Class 1
Bit, Surgical
Regulation 878.4820
0510(k)s in 12 months (3 all time)
0recalls in 12 months (17 all time)
0recalls that name a 510(k)
Top companies in GFG
| Company | 510(k)s | Recalls |
|---|---|---|
| Smith & Nephew, Inc. | 0 | 14 |
| Biomet, Inc. | 0 | 1 |
| Key Medical, Inc. | 1 | 0 |
| Mitek Surgical Products, Inc. | 1 | 0 |
| Spire Medical, Inc. | 1 | 0 |
| Synthes, Inc. | 0 | 1 |
| Zimmer Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 7, 1994 | K935225 | MITEK MODULAR DRILL BIT Mitek Surgical Products, Inc. | GFG |
| Jun 9, 1982 | K821486 | MICRO DRILLS Spire Medical, Inc. | GFG |
| Jun 3, 1982 | K821127 | KEY DRILL Key Medical, Inc. | GFG |
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