Clearance Summary
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS received FDA 510(k) clearance under submission number K030958, sponsored by Ortho Tec, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2003-11-20.
- Submission: K030958
- Applicant / Sponsor: Ortho Tec, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2003-11-20
Classification & Regulation
This clearance is catalogued under FDA product code MNI and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.