Cleared Special

ATLAS SPINE PEDICLE SCREW SYSTEM

K110842 · Atlas Spine, Inc. · Orthopedic

Jul 2011

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K110842 is an FDA 510(k) clearance for the ATLAS SPINE PEDICLE SCREW SYSTEM, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on July 13, 2011, 110 days after receiving the submission on March 25, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K110842 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2011
Decision Date	July 13, 2011
Days to Decision	110 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.