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 IDK143569
510k NumberK143569
Device Name:CD HORIZON Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis,  TN  38132
ContactGregory Maschek
CorrespondentGregory Maschek
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 Received2014-12-16
Decision Date2015-02-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00643169357792 K143569 000
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00643169207219 K143569 000
00643169207141 K143569 000
00643169206670 K143569 000

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