510(k) K973524 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ADVANCE MODULAR TIBIAL COMPONENT
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent for Some Indications, Dec 12, 1997 |
| Received | Sep 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973524
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2010 | Wright Medical Technology Inc ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE NON-POROUS, 1 EACH, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002.
The device is intended for us Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.