510(k) K960538 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
OPTEON UNIPOLAR
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Mar 27, 1996 |
| Received | Feb 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960538
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.