Cervical Spine Truss System (CSTS)— 510(k) K251117

Name: FDA 510(k) clearance K251117
Creator: U.S. Food and Drug Administration
Published: 2025-04-25

Substantially Equivalent

4Web Medical

FDA 510(k) clearance K251117 for Cervical Spine Truss System (CSTS), Substantially Equivalent on 2025-04-25. Applicant: 4Web Medical. Device class: 2.

Clearance details

Applicant: 4Web Medical
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-04-11
Decision date: 2025-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Frisco, TX, US

Download summary PDF View on FDA.gov ↗

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K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
K261451 — ZSAlign Cervical Interbody System2026-07-31
K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

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K252834 — Sacroiliac Joint Truss System (SJTS)2026-01-28

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.