Cleared Traditional

Atlas Spine Lateral Expandable Interbody System

K243191 · Atlas Spine, Inc. · Orthopedic

Nov 2024

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K243191 is an FDA 510(k) clearance for the Atlas Spine Lateral Expandable Interbody System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on November 26, 2024, 57 days after receiving the submission on September 30, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K243191 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	November 26, 2024
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

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.