Panels › Orthopedic › Product code HXY · Class 1
Brace, Drill
Regulation 888.4540
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in HXY
| Company | 510(k)s | Recalls |
|---|---|---|
| Orthopedic Systems, Inc. | 2 | 0 |
| Austin Assoc. | 1 | 0 |
| Buckman Co., Inc. | 1 | 0 |
| Depuy, Inc. | 1 | 0 |
| Mitek Surgical Products, Inc. | 1 | 0 |
| Musculoskeletal Transplant Foundation, Inc. | 0 | 1 |
| Neimark Labs, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 1992 | K923776 | BENDEREV DRILL GUIDE Neimark Labs, Inc. | HXY |
| Sep 28, 1989 | K892904 | MITEK DRILL GUIDE Mitek Surgical Products, Inc. | HXY |
| Mar 23, 1988 | K880264 | BONE SUTURE FIXATION DEVICE Orthopedic Systems, Inc. | HXY |
| Mar 15, 1988 | K880381 | TELOS DISTAL TARGETING DEVICE Austin Assoc. | HXY |
| Feb 16, 1988 | K880046 | HASTING FINGER FIXATOR INSTRUMENTS Buckman Co., Inc. | HXY |
| Apr 28, 1983 | K831043 | ANDREWS REMOTE CHUCK DRILL Orthopedic Systems, Inc. | HXY |
| Feb 8, 1977 | K770204 | CEMENT EXTRACTOR DRILL Depuy, Inc. | HXY |
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