CD HORIZON® Spinal System

Thoracolumbosacral Pedicle Screw System

MEDTRONIC SOFAMOR DANEK USA, INC

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Cd Horizon® Spinal System.

Pre-market Notification Details

Device IDK162494
510k NumberK162494
Device Name:CD HORIZON® Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis,  TN  38132
ContactJustin O'connor
CorrespondentJustin O'connor
MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-07
Decision Date2016-10-04
Summary:summary

Trademark Results [CD HORIZON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CD HORIZON
CD HORIZON
75079759 2108361 Live/Registered
WARSAW ORTHOPEDIC, INC.
1996-03-28

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