Clearance Summary
SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides received FDA 510(k) clearance under submission number K163156, 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 2017-01-18.
- Submission: K163156
- Applicant / Sponsor: Materialise NV
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2017-01-18
Classification & Regulation
This clearance is catalogued under FDA product code PBF and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.