Clearance Summary
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM received FDA 510(k) clearance under submission number K130814, sponsored by Depuy Mitek, A Johnson & Johnson Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-08-01.
- Submission: K130814
- Applicant / Sponsor: Depuy Mitek, A Johnson & Johnson Company
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2013-08-01
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.