510(k) K091263 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Nov 19, 2009 |
| Received | Apr 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091263
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.