Clearance Summary
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 received FDA 510(k) clearance under submission number K031452, sponsored by Ortho Tec, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2003-06-18.
- Submission: K031452
- Applicant / Sponsor: Ortho Tec, LLC
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 2003-06-18
Classification & Regulation
This clearance is catalogued under FDA product code KWP and 21 CFR 888.3050, within the Orthopedic review panel as a Class II device.