K242813
- 510(k) number
- K242813
- 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
- 2024-10-18
- Date received
- 2024-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K242813.pdf
Official FDA record: K242813
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.