510(k) K260802 · QHE Shoulder Arthroplasty Implantation System
Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Jun 9, 2026 |
| Received | Mar 11, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260802
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.