510(k) K173970 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Materialise PKA Guide System
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Jul 6, 2018 |
| Received | Dec 29, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173970
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.