Clearance Summary
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 received FDA 510(k) clearance under submission number K001378, sponsored by Bionx Implants, 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 2000-07-28.
- Submission: K001378
- Applicant / Sponsor: Bionx Implants, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2000-07-28
Classification & Regulation
This clearance is catalogued under FDA product code MAI and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.