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

Name: FDA 510(k) clearance K253200
Creator: U.S. Food and Drug Administration
Published: 2025-12-11

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.. Device class: 2.

Clearance details

Applicant: 4Web Medical, Inc.
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
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 ↗

Recent devices under product code OVE

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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

More clearances from 4Web Medical, Inc.

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K240388 — Osteotomy Truss System (OTS)2024-11-01
K233966 — Anterior Spine Truss System-Stand Alone (ASTS-SA)2024-04-22
K230088 — Ankle Truss System (ATS)2024-03-21
K231739 — Cervical Spine Truss System (CSTS)2023-09-25
K223362 — Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device2023-02-02

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.