Clearance Summary
OSTAPEK VBR SYSTEM received FDA 510(k) clearance under submission number K072326, 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 2008-06-24.
- Submission: K072326
- Applicant / Sponsor: Co-Ligne AG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2008-06-24
Classification & Regulation
This clearance is catalogued under FDA product code MQP and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.