510(k) K103419 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Dec 13, 2010 |
| Received | Nov 22, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103419
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with:
a) 38, 41, 44, 47 head, Small, Item Number 314-02-22,
b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23,
c Open, Classified |
KWS | None listed |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with:
a) 38, 41, 44, 47 head, Small, Item Number 314-02-32,
b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33,
Open, Classified |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.