510(k) K111379 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jun 8, 2011 |
| Received | May 17, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111379
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with:
a) 38, 41, 44, 47 head, Small, Item Number 314-04-22,
b) 41, 44, 47, 50 head, Medium, Item Number Open, Classified |
KWS | None listed |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with:
a) 38, 41, 44, 47 head, Small, Item Number 314-04-32,
b) 41, 44, 47, 50 head, Medium, Item Numbe Open, Classified |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.