Clearance Summary
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM received FDA 510(k) clearance under submission number K121627, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2012-10-15.
- Submission: K121627
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2012-10-15
Classification & Regulation
This clearance is catalogued under FDA product code MEH and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.