510(k) K032824 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
STELKAST UNICONDYLAR KNEE SYSTEM
| Applicant | Stelkast Company, Mcmurray PA, US |
| Decision | Substantially Equivalent, Nov 13, 2003 |
| Received | Sep 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032824
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2009 | Stelkast Co Stelkast Unicondylar Knee Femoral Component SC2462-1.
Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee impl Terminated |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.