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 IDK162379
510k NumberK162379
Device Name:CD HORIZON® Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 Pyramid Place Memphis,  TN  38132
ContactNathaniel Hendricks
CorrespondentBecky Ronner
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-24
Decision Date2016-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169792029 K162379 000
00643169761957 K162379 000
00643169761940 K162379 000
00643169761933 K162379 000
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00643169761919 K162379 000
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00643169761896 K162379 000
00643169761889 K162379 000
00643169761872 K162379 000
00643169761865 K162379 000
00643169761629 K162379 000
00643169761964 K162379 000
00643169761971 K162379 000
00643169792012 K162379 000
00643169792005 K162379 000
00643169791992 K162379 000
00643169791985 K162379 000
00643169791978 K162379 000
00643169763104 K162379 000
00643169763098 K162379 000
00643169762015 K162379 000
00643169762008 K162379 000
00643169761995 K162379 000
00643169761988 K162379 000
00643169761612 K162379 000

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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