510(k) K123907 ยท KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 3, 2013 |
| Received | Dec 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123907
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2016 | Biomet, Inc. All instrumentation associated with the Prelude PF Resurfacing Knee System. Terminated |
KRR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.