K233191
- 510(k) number
- K233191
- Device name
- TotalTi ACDF by SAGICO
- Applicant
- Spinal Analytics & Geometrical Implant Co, LLC FL · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2023-11-21
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K233191.pdf
Official FDA record: K233191
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.