Cervical Spinal Truss System-Stand Alone (CSTS-SA)— 510(k) K190870

Name: FDA 510(k) clearance K190870
Creator: U.S. Food and Drug Administration
Published: 2019-08-12

Substantially Equivalent

4Web, Inc.

FDA 510(k) clearance K190870 for Cervical Spinal Truss System-Stand Alone (CSTS-SA), Substantially Equivalent on 2019-08-12. Applicant: 4Web, Inc.. Device class: 2.

Clearance details

Applicant: 4Web, Inc.
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2019-04-03
Decision date: 2019-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frisco, TX, US

Download summary PDF View on FDA.gov ↗

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K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

More clearances from 4Web, Inc.

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K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS)2026-02-12
K203065 — Lumbar Spine Truss System Plating Solution (LSTS-PS)2021-03-10
K200002 — Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device2020-05-29
K190926 — Hammertoe Truss System (HTS)2019-07-23
K172294 — Osteotomy Truss System (OTS)2018-02-22

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.