510(k) K954208 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent for Some Indications, Feb 26, 1996 |
| Received | Sep 7, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954208
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2024 | Exactech, Inc. Exactech Optetrak Knee System, Catalog Numbers:
a) 200-02-26,
b) 200-02-29,
c) 200-02-32,
d) 200-02-35,
e) 200-02-38,
f) 200-02-41,
g) 200-03-32,
h) 200-07-29,
i) 200-07-32,
j) 200-07-35,
Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.