Clearance Summary
RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL received FDA 510(k) clearance under submission number K140324, sponsored by Depuy Mitek, A Johnson and 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 2014-07-07.
- Submission: K140324
- Applicant / Sponsor: Depuy Mitek, A Johnson and Johnson Company
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2014-07-07
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.