Clearance Summary
GII SPINAL FIXATION SYSTEM received FDA 510(k) clearance under submission number K032604, sponsored by Co-Ligne AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-01-20.
- Submission: K032604
- Applicant / Sponsor: Co-Ligne AG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2004-01-20
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.