510(k) K932776 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent for Some Indications, Oct 20, 1994 |
| Received | Jun 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932776
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2006 | Exactech, Inc. Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE O Terminated |
JWH | None listed |
| Aug 18, 2005 | Exactech, Inc. The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CE Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.