Anterior Spine Truss System-Stand Alone (ASTS-SA)— 510(k) K233966

Name: FDA 510(k) clearance K233966
Creator: U.S. Food and Drug Administration
Published: 2024-04-22

Substantially Equivalent

4Web Medical, Inc.

FDA 510(k) clearance K233966 for Anterior Spine Truss System-Stand Alone (ASTS-SA), Substantially Equivalent on 2024-04-22. Applicant: 4Web Medical, Inc.. Device class: 2.

Clearance details

Applicant: 4Web Medical, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2023-12-15
Decision date: 2024-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frisco, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

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K261408 — SABER-XA System2026-08-03
K261809 — Interwedge® Standalone Lateral2026-07-31
K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K260810 — Anteralign LS coverplate2026-06-10
K254202 — MectaLIF 3D Metal Anterior2026-05-05

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
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 OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.