510(k) K010434 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Mar 13, 2001 |
| Received | Feb 13, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010434
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2006 | Exactech, Inc. Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.