Clearance Summary
TotalTi ACDF by SAGICO received FDA 510(k) clearance under submission number K233191, sponsored by Spinal Analytics & Geometrical Implant Co, 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 2023-11-21.
- Submission: K233191
- Applicant / Sponsor: Spinal Analytics & Geometrical Implant Co, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2023-11-21
Classification & Regulation
This clearance is catalogued under FDA product code OVE and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.