Clearance Summary
Smart SPACE Shoulder Planner and 3D Positioners received FDA 510(k) clearance under submission number K222405, sponsored by Lima Corporate S.P.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 2022-12-20.
- Submission: K222405
- Applicant / Sponsor: Lima Corporate S.P.A.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2022-12-20
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.