510(k) K112301 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Jan 6, 2012 |
| Received | Aug 10, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112301
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.