K231112
- 510(k) number
- K231112
- 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
- 2023-09-12
- Date received
- 2023-04-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231112.pdf
Official FDA record: K231112
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.