510(k) K060107 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Feb 6, 2006 |
| Received | Jan 13, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060107
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2021 | Exactech, Inc. Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. 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.