510(k) K080936 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS
| Applicant | Conformis, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, May 12, 2008 |
| Received | Apr 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080936
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.