Clearance Summary
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 received FDA 510(k) clearance under submission number K012334, sponsored by Bionx Implants, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2001-09-19.
- Submission: K012334
- Applicant / Sponsor: Bionx Implants, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2001-09-19
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.