510(k) K092441 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM
| Applicant | Conformis, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Sep 9, 2009 |
| Received | Aug 10, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092441
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.