510(k) K963313 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
EXACTECH ALL POLY ACETABULAR CUP
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Nov 14, 1996 |
| Received | Aug 22, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963313
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2022 | Exactech, Inc. GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42;
b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTE Open, Classified |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.