510(k) K040601 ยท KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Oct 4, 2004 |
| Received | Mar 8, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K040601
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2022 | Exactech, Inc. GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05;
b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, RE Open, Classified |
KWZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.