Clearance Summary
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS received FDA 510(k) clearance under submission number K092386, 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 2009-11-03.
- Submission: K092386
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2009-11-03
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.