510(k) K040613 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jun 4, 2004 |
| Received | Mar 9, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040613
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2022 | Exactech, Inc. GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03
b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04 Open, Classified |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.