Clearance Summary
LEGION Porous CR Narrow Femoral Components received FDA 510(k) clearance under submission number K210566, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-03-25.
- Submission: K210566
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3565
- Decision date: 2021-03-25
Classification & Regulation
This clearance is catalogued under FDA product code MBH and 21 CFR 888.3565, within the Orthopedic review panel as a Class II device.