Cleared Traditional

Anterior Spine Truss System-Stand Alone (ASTS-SA)

K233966 · 4Web Medical, Inc. · Orthopedic

Apr 2024

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K233966 is an FDA 510(k) clearance for the Anterior Spine Truss System-Stand Alone (ASTS-SA), a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by 4Web Medical, Inc. (Frisco, US). The FDA issued a Cleared decision on April 22, 2024, 129 days after receiving the submission on December 15, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K233966 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2023
Decision Date	April 22, 2024
Days to Decision	129 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.