Clearance Summary
INION SPINAL GRAFT CONTAINMENT SYSTEM received FDA 510(k) clearance under submission number K071810, sponsored by Inion , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2008-07-11.
- Submission: K071810
- Applicant / Sponsor: Inion , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2008-07-11
Classification & Regulation
This clearance is catalogued under FDA product code OJB and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.