Clearance Summary
INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM received FDA 510(k) clearance under submission number K051821, 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 2005-11-25.
- Submission: K051821
- Applicant / Sponsor: Inion , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2005-11-25
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.