Clearance Summary
R3 XLPE ANTEVERTED LINERS received FDA 510(k) clearance under submission number K102370, 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 2011-01-19.
- Submission: K102370
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2011-01-19
Classification & Regulation
This clearance is catalogued under FDA product code MBL and 21 CFR 888.3358, within the Orthopedic review panel as a Class II device.