510(k) K040889 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
EXACTECH OPTETRAK UNICONDYLAR KNEE
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Oct 1, 2004 |
| Received | Apr 5, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040889
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2021 | Exactech, Inc. OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX.
NOTE: Information reflects Exactech recall e Open, Classified |
HRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.