510(k) K032964 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Nov 13, 2003 |
| Received | Sep 23, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032964
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2008 | Exactech, Inc. Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653 Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.