Clearance Summary
3D-Cut received FDA 510(k) clearance under submission number K212237, sponsored by 3D-Side S.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-11-29.
- Submission: K212237
- Applicant / Sponsor: 3D-Side S.A.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2021-11-29
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.