Clearance Summary
STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM received FDA 510(k) clearance under submission number K073109, sponsored by Surgicraft , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2008-06-04.
- Submission: K073109
- Applicant / Sponsor: Surgicraft , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2008-06-04
Classification & Regulation
This clearance is catalogued under FDA product code OVD and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.