Clearance Summary
REFLECTION CONSTRAINED LINER received FDA 510(k) clearance under submission number K021803, 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 2002-12-19.
- Submission: K021803
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3310
- Decision date: 2002-12-19
Classification & Regulation
This clearance is catalogued under FDA product code KWZ and 21 CFR 888.3310, within the Orthopedic review panel as a Class II device.