Cleared Traditional

CD HORIZON SPINAL SYSTEM

K140276 · Medtronic Sofamor Danek · Orthopedic

Mar 2014

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K140276 is an FDA 510(k) clearance for the CD HORIZON SPINAL SYSTEM, a Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (Class II — Special Controls, product code OSH), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on March 13, 2014, 38 days after receiving the submission on February 3, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K140276 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2014
Decision Date	March 13, 2014
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OSH — Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Stabilize The Thoracolumbar Spine As An Adjunct To Fusion Using Allograft And/or Autograft To Treat Adolescent Idiopathic Scoliosis.