Clearance Summary
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 received FDA 510(k) clearance under submission number K042713, sponsored by Spine Next America Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-12-29.
- Submission: K042713
- Applicant / Sponsor: Spine Next America Corporation
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2004-12-29
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.