Cleared Traditional

Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device

K223362 · 4Web Medical, Inc. · Orthopedic

Feb 2023

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K223362 is an FDA 510(k) clearance for the Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device, 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 February 2, 2023, 91 days after receiving the submission on November 3, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K223362 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 2022
Decision Date	February 02, 2023
Days to Decision	91 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.