Cleared Traditional

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

K190870 · 4Web, Inc. · Orthopedic

Aug 2019

Decision

131d

Days

Class 2

Risk

About This 510(k) Submission

K190870 is an FDA 510(k) clearance for the Cervical Spinal Truss System-Stand Alone (CSTS-SA), a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by 4Web, Inc. (Frisco, US). The FDA issued a Cleared decision on August 12, 2019, 131 days after receiving the submission on April 3, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K190870 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2019
Decision Date	August 12, 2019
Days to Decision	131 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.