510(k) K021908 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL
| Applicant | Stelkast Company, Mcmurray PA, US |
| Decision | Substantially Equivalent, Jul 9, 2002 |
| Received | Jun 10, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021908
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2013 | Stelkast Co SC2316, Distal Femoral Augment with Screw
Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.