Clearance Summary
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II received FDA 510(k) clearance under submission number K012788, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2002-03-15.
- Submission: K012788
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2002-03-15
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.