Clearance Summary
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) received FDA 510(k) clearance under submission number K131683, sponsored by Depuy Mitek, Inc., A Johnson and Johnson Company. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-06-27.
- Submission: K131683
- Applicant / Sponsor: Depuy Mitek, Inc., A Johnson and Johnson Company
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2013-06-27
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.