Clearance Summary
OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) received FDA 510(k) clearance under submission number K043349, sponsored by Ldr Spine USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2005-06-29.
- Submission: K043349
- Applicant / Sponsor: Ldr Spine USA
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2005-06-29
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.