Cleared Traditional

ATLAS SPINE PIVOTING SYSTEM

K100743 · Atlas Spine, Inc. · Orthopedic

Aug 2010

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K100743 is an FDA 510(k) clearance for the ATLAS SPINE PIVOTING 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 August 10, 2010, 147 days after receiving the submission on March 16, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K100743 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 2010
Decision Date	August 10, 2010
Days to Decision	147 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.