Cleared Traditional

Anterior Spine Truss System ? Stand Alone (ASTS-SA) Interbody Fusion Device

K200002 · 4Web, Inc. · Orthopedic

May 2020

Decision

148d

Days

Class 2

Risk

About This 510(k) Submission

K200002 is an FDA 510(k) clearance for the Anterior Spine Truss System ? Stand Alone (ASTS-SA) Interbody Fusion Device, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by 4Web, Inc. (Frisco, US). The FDA issued a Cleared decision on May 29, 2020, 148 days after receiving the submission on January 2, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K200002 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 2020
Decision Date	May 29, 2020
Days to Decision	148 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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