Clearance Summary
CORE PEDICLE SCREW SYSTEM received FDA 510(k) clearance under submission number K131522, sponsored by Core-Nexus. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-08-09.
- Submission: K131522
- Applicant / Sponsor: Core-Nexus
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2013-08-09
Classification & Regulation
This clearance is catalogued under FDA product code MNI and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.