Cleared Traditional

Cervical Spine Truss System (CSTS)

K231739 · 4Web Medical, Inc. · Orthopedic

Sep 2023

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K231739 is an FDA 510(k) clearance for the Cervical Spine Truss System (CSTS), 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 September 25, 2023, 103 days after receiving the submission on June 14, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K231739 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 2023
Decision Date	September 25, 2023
Days to Decision	103 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.