K260802
- 510(k) number
- K260802
- Device name
- Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- Applicant
- Materialise NV BE
- Product code
- QHE — Shoulder Arthroplasty Implantation System
- Decision date
- 2026-06-09
- Date received
- 2026-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260802.pdf
Official FDA record: K260802
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.