Cleared Traditional

Atlas Spine Expandable Cervical Standalone Interbody System

K192570 · Atlas Spine, Inc. · Orthopedic

Feb 2020

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K192570 is an FDA 510(k) clearance for the Atlas Spine Expandable Cervical Standalone Interbody System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on February 28, 2020, 163 days after receiving the submission on September 18, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K192570 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2019
Decision Date	February 28, 2020
Days to Decision	163 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

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.