510(k) K993082 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Nov 19, 1999 |
| Received | Sep 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993082
| 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 0 DEGREE LINER 28MM 46MM, REF 130-28-05;
b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06;
c. ACUMATC Open, Classified |
JDI | None listed |
| Nov 7, 2016 | Exactech, Inc. AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J. Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.