510(k) K212356 · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Exactech® Equinoxe® Laser Cage Glenoid
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Mar 4, 2022 |
| Received | Jul 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212356
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2024 | Exactech, Inc. Exactech Equinoxe Shoulder System, Catalog Numbers:
a) 314-23-02,
b) 314-23-03,
c) 314-23-13,
d) 314-23-14,
e) 314-23-15,
f) 314-24-22,
g) 314-24-23,
h) 314-24-24,
i) 314-24-32,
j) 314-24-3 Open, Classified |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.