510(k) K973164 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS
| Applicant | Howmedica Corp., Rutherford NJ, US |
| Decision | Substantially Equivalent for Some Indications, Nov 20, 1997 |
| Received | Aug 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973164
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adapto Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.