Cervical Spine Truss System - Stand Alone (CSTS-SA)— 510(k) K253200

Substantially Equivalent

4Web Medical, Inc.

FDA 510(k) clearance K253200 for Cervical Spine Truss System - Stand Alone (CSTS-SA), Substantially Equivalent on 2025-12-11. Applicant: 4Web Medical, Inc..

Clearance details

Applicant: 4Web Medical, Inc.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2025-09-26
Decision date: 2025-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frisco, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.