Clearance Summary
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, received FDA 510(k) clearance under submission number K100858, sponsored by Lima-Lto 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 2010-12-10.
- Submission: K100858
- Applicant / Sponsor: Lima-Lto S.P.A.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3650
- Decision date: 2010-12-10
Classification & Regulation
This clearance is catalogued under FDA product code KWT and 21 CFR 888.3650, within the Orthopedic review panel as a Class II device.