Clearance Summary
Smith and Nephew Legion Hinge Knee System received FDA 510(k) clearance under submission number K151118, sponsored by Smith & Nephew. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2015-07-28.
- Submission: K151118
- Applicant / Sponsor: Smith & Nephew
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3510
- Decision date: 2015-07-28
Classification & Regulation
This clearance is catalogued under FDA product code KRO and 21 CFR 888.3510, within the Orthopedic review panel as a Class II device.