K253200
- 510(k) number
- K253200
- Device name
- Cervical Spine Truss System - Stand Alone (CSTS-SA)
- Applicant
- 4Web Medical, Inc. TX · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-12-11
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K253200.pdf
Official FDA record: K253200
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.