Cleared Traditional

Cervical Spine Truss System - Stand Alone (CSTS-SA)

K253200 · 4Web Medical, Inc. · Orthopedic

Dec 2025

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K253200 is an FDA 510(k) clearance for the Cervical Spine Truss System - Stand Alone (CSTS-SA), a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by 4Web Medical, Inc. (Frisco, US). The FDA issued a Cleared decision on December 11, 2025, 76 days after receiving the submission on September 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K253200 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2025
Decision Date	December 11, 2025
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.