Osteotomy Truss System (OTS)— 510(k) K240388

Name: FDA 510(k) clearance K240388
Creator: U.S. Food and Drug Administration
Published: 2024-11-01

Substantially Equivalent

4Web Medical, Inc.

FDA 510(k) clearance K240388 for Osteotomy Truss System (OTS), Substantially Equivalent on 2024-11-01. Applicant: 4Web Medical, Inc.. Device class: 2.

Clearance details

Applicant: 4Web Medical, Inc.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2024-02-08
Decision date: 2024-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frisco, TX, US

Download summary PDF View on FDA.gov ↗

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K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA)2025-12-11
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 HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.