Panels › Orthopedic › Product code HTX · Class 1
Rongeur
Regulation 888.4540
0510(k)s in 12 months (5 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in HTX
| Company | 510(k)s | Recalls |
|---|---|---|
| Exactech, Inc. | 0 | 6 |
| Plastafil, Inc. | 2 | 0 |
| Depuy, Inc. | 1 | 0 |
| Orthopedic Equipment Co., Inc. | 1 | 0 |
| Sklar Instruments | 0 | 1 |
| Solway, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 30, 1987 | K874954 | MANUAL RONGEUR Solway, Inc. | HTX |
| Sep 20, 1984 | K841621 | BACK RADIUS CUTTER Plastafil, Inc. | HTX |
| Sep 20, 1984 | K841620 | FRONT RADIUS CUTTER Plastafil, Inc. | HTX |
| Mar 22, 1978 | K780397 | ORTHOPEDIC FORCEPS Orthopedic Equipment Co., Inc. | HTX |
| Aug 3, 1976 | K760325 | SURGICAL INSTRUMENTS, ORTHOPEDIC Depuy, Inc. | HTX |
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