510(k) K050398 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Nov 18, 2005 |
| Received | Feb 16, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050398
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2021 | Exactech, Inc. Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component. Completed |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.