510(k) K122883 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
| Applicant | Stelkast Company, Mcmurray PA, US |
| Decision | Substantially Equivalent, Aug 5, 2013 |
| Received | Sep 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122883
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2015 | Stelkast Co EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.