510(k) K173875 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
| Applicant | Stelkast, Inc., Mcmurray PA, US |
| Decision | Substantially Equivalent, Jan 19, 2018 |
| Received | Dec 21, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173875
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.