Clearance Summary
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS received FDA 510(k) clearance under submission number K030344, 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 2003-03-04.
- Submission: K030344
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2003-03-04
Classification & Regulation
This clearance is catalogued under FDA product code KWS and 21 CFR 888.3660, within the Orthopedic review panel as a Class II device.