Clearance Summary
GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW received FDA 510(k) clearance under submission number K083567, sponsored by Co-Ligne AG. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2009-09-14.
- Submission: K083567
- Applicant / Sponsor: Co-Ligne AG
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2009-09-14
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.