Clearance Summary
NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION received FDA 510(k) clearance under submission number K934166, sponsored by Corin Orthopedic Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1994-09-07.
- Submission: K934166
- Applicant / Sponsor: Corin Orthopedic Products
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 1994-09-07
Classification & Regulation
This clearance is catalogued under FDA product code JWH and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.