Cleared Traditional

CD HORIZON SPINAL SYSTEM

K111457 · Medtronic Sofamor Danek · Orthopedic

Sep 2011

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K111457 is an FDA 510(k) clearance for the CD HORIZON 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 September 15, 2011, 112 days after receiving the submission on May 26, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K111457 FDA.gov
FDA Decision	Cleared SESU
Date Received	May 26, 2011
Decision Date	September 15, 2011
Days to Decision	112 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.