Clearance Summary
Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner received FDA 510(k) clearance under submission number K212569, sponsored by Materialise NV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-01-12.
- Submission: K212569
- Applicant / Sponsor: Materialise NV
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2022-01-12
Classification & Regulation
This clearance is catalogued under FDA product code QHE and 21 CFR 888.3660, within the Orthopedic review panel as a Class II device.