510(k) K980276 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM
| Applicant | Stelkast Company, Pittsburgh PA, US |
| Decision | Substantially Equivalent, Apr 24, 1998 |
| Received | Jan 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980276
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2008 | Stelkast Co Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm.
The Proven Knee System is a single use device intended for cemented reconstruction of the f Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.