510(k) K230315 · QHE Shoulder Arthroplasty Implantation System
Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Mar 6, 2023 |
| Received | Feb 6, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230315
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.