510(k) K162222 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
GENflex2 Total Knee System
| Applicant | Stelkast, Inc., Mcmurray PA, US |
| Decision | Substantially Equivalent, Sep 7, 2016 |
| Received | Aug 8, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162222
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.