510(k) K071676 ยท KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jul 19, 2007 |
| Received | Jun 19, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071676
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2024 | Exactech, Inc. Exactech Novation Hip System, Catalog Numbers: 134-36-45 Open, Classified |
KWZ | None listed |
| Aug 11, 2022 | Exactech, Inc. GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41
b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 1 Open, Classified |
KWZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.