Panels › Orthopedic › Product code HWR · Class 1
Driver, Prosthesis
Regulation 888.4540
0510(k)s in 12 months (4 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in HWR
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet U.K., Ltd. | 0 | 2 |
| Warsaw Orthopedic, Inc. | 2 | 0 |
| Biomet Microfixation, Inc. | 0 | 1 |
| Buckman Co., Inc. | 1 | 0 |
| Kim-Med, Inc. | 1 | 0 |
| Pioneer Surgical Technology | 0 | 1 |
| Smith & Nephew, Inc., Endoscopy Div. | 0 | 1 |
| Wright Medical Technology Inc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 11, 1992 | K915776 | KNEE PROSTHESIS DRIVER Kim-Med, Inc. | HWR |
| Jan 28, 1988 | K875054 | ACROMED ADS BONE NAIL DRIVER Buckman Co., Inc. | HWR |
| Mar 13, 1987 | K870848 | SCHULTZ METACARPAL COMPONENT DRIVER Warsaw Orthopedic, Inc. | HWR |
| Mar 13, 1987 | K870847 | SCHULTZ PHALANGEAL COMPONENT DRIVER Warsaw Orthopedic, Inc. | HWR |
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