Clearance Summary
CONTOUR HA COATED RECONSTRUCTION RING received FDA 510(k) clearance under submission number K040680, 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 2004-06-14.
- Submission: K040680
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2004-06-14
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.