510(k) K013211 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Dec 5, 2001 |
| Received | Sep 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013211
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2024 | Exactech, Inc. Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers:
a) 100-22-19, SZ. L;
b) 100-22-20, SZ. M;
c) 100-22-21, SZ. N;
d) 100-22-22, SZ. P;
e) 100-22-23, SZ. R;
f) 1 Open, Classified |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.