Panels › Orthopedic › Product code HWA · Class 1
Impactor
Regulation 888.4540
0510(k)s in 12 months (4 all time)
2recalls in 12 months (27 all time)
2recalls that name a 510(k)
Top companies in HWA
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Howmedica Osteonics | 0 | 7 |
| Encore Medical, Lp | 0 | 5 |
| Exactech, Inc. | 0 | 4 |
| Zimmer Inc. | 0 | 3 |
| Greatbatch Medical | 0 | 2 |
| Cedar Surgical, Inc. | 1 | 0 |
| Depuy, Inc. | 1 | 0 |
| DePuy Orthopaedics, Inc. | 0 | 1 |
| Enztec Limited | 0 | 1 |
| INCIPIO DEVICES | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 1994 | K933527 | MODIFICATION OF ANTERIOR SEGMENT ELECTRODES Mira, Inc. | HWA |
| Nov 24, 1986 | K864422 | RAYLOR(TM) MALLET Cedar Surgical, Inc. | HWA |
| Aug 27, 1984 | K841627 | MALLET Plastafil, Inc. | HWA |
| Feb 8, 1977 | K770205 | CEMENT CHISELS Depuy, Inc. | HWA |
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