Cleared Traditional

ATLAS SPINE SPACER

K081880 · Atlas Spine, Inc. · Orthopedic

Oct 2008

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K081880 is an FDA 510(k) clearance for the ATLAS SPINE SPACER, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on October 2, 2008, 92 days after receiving the submission on July 2, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K081880 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2008
Decision Date	October 02, 2008
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, 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.