510(k) K971938 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
REPICCI II UNICONDYLAR KNEE
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 25, 1997 |
| Received | May 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971938
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2017 | Zimmer Biomet, Inc. various polyethylene implants
Sports Med
Repicci II Tibial Components
Product Usage:
Partial knee replacement Terminated |
HRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.