Cleared Traditional

CD HORIZON VOYAGER SPINAL SYSTEM

K113529 · Medtronic Sofamor Danek · Orthopedic

Feb 2012

Decision

71d

Days

Class 2

Risk

About This 510(k) Submission

K113529 is an FDA 510(k) clearance for the CD HORIZON VOYAGER SPINAL SYSTEM, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on February 9, 2012, 71 days after receiving the submission on November 30, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K113529 FDA.gov
FDA Decision	Cleared SESU
Date Received	November 30, 2011
Decision Date	February 09, 2012
Days to Decision	71 days
Submission Type	Traditional
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.