510(k) K093430 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Sep 2, 2010 |
| Received | Nov 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093430
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes:
a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Open, Classified |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.