510(k) K933494 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent for Some Indications, Mar 10, 1995 |
| Received | Jul 19, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933494
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2021 | Exactech, Inc. OPTETRAK Comprehensive Knee System, labeled as the following:
a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200 Open, Classified |
JWH | None listed |
| Feb 27, 2007 | Exactech, Inc. Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.