Lateral Spine Truss System (LSTS) Interbody Fusion Device— 510(k) K211388

Name: FDA 510(k) clearance K211388
Creator: U.S. Food and Drug Administration
Published: 2021-08-05

Substantially Equivalent

4Web Medical, Inc.

FDA 510(k) clearance K211388 for Lateral Spine Truss System (LSTS) Interbody Fusion Device, Substantially Equivalent on 2021-08-05. Applicant: 4Web Medical, Inc.. Device class: 2.

Clearance details

Applicant: 4Web Medical, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2021-05-05
Decision date: 2021-08-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Frisco, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from 4Web Medical, Inc.

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

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.