Chisel, Osteotome, Surgical
Regulation 872.4565
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in EMM
| Company | 510(k)s | Recalls |
|---|---|---|
| American Safety Equipment Corp. | 1 | 0 |
| Artiberia | 1 | 0 |
| Biomet Microfixation, Inc. | 0 | 1 |
| New England Surgical Instrument Corp. | 1 | 0 |
| Steri-Oss, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 1996 | K963897 | STERI-OSS SINUS AUGMENTATION KIT Steri-Oss, Inc. | EMM |
| Feb 12, 1987 | K864775 | CHISEL (OSTEOTOME, GOUGE, ETC.) New England Surgical Instrument Corp. | EMM |
| Jun 11, 1985 | K851714 | 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS Artiberia | EMM |
| Nov 15, 1976 | K760959 | SURGICAL CHISEL American Safety Equipment Corp. | EMM |
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