Cleared Traditional

Atlas Spine Expandable Interbody System

K162918 · Atlas Spine, Inc. · Orthopedic

Feb 2017

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K162918 is an FDA 510(k) clearance for the Atlas Spine Expandable Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on February 9, 2017, 114 days after receiving the submission on October 18, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K162918 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2016
Decision Date	February 09, 2017
Days to Decision	114 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.