510(k) K041906 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
EXACTECH 12/14 TOTAL HIP SYSTEM
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Sep 10, 2004 |
| Received | Jul 15, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041906
| 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 +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08
b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, R Open, Classified |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.