Clearance Summary
4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, received FDA 510(k) clearance under submission number K142574, sponsored by Depuy Mitek, A Johnson & 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 2014-10-24.
- Submission: K142574
- Applicant / Sponsor: Depuy Mitek, A Johnson & Johnson Company
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2014-10-24
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.