510(k) K193560 ยท QHE Shoulder Arthroplasty Implantation System
Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Mar 20, 2020 |
| Received | Dec 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193560
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.