Clearance Summary
GALLEON PEDICLE SCREW SYSTEM received FDA 510(k) clearance under submission number K122814, sponsored by Everest Spine, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2012-12-03.
- Submission: K122814
- Applicant / Sponsor: Everest Spine, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2012-12-03
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.