510(k) K094050 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ITOTAL CR KNEE REPLACEMENT SYSTEM
| Applicant | Conformis, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Sep 16, 2010 |
| Received | Dec 31, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K094050
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.