Clearance Summary
ALIF SPINAL TRUSS INTERBODY FUSION DEVICE received FDA 510(k) clearance under submission number K083894, sponsored by 4-Web Spine, 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 2011-01-18.
- Submission: K083894
- Applicant / Sponsor: 4-Web Spine, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2011-01-18
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.