K251117
- 510(k) number
- K251117
- Device name
- Cervical Spine Truss System (CSTS)
- Applicant
- 4Web Medical TX · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-04-25
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K251117.pdf
Official FDA record: K251117
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.