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 IDK153589
510k NumberK153589
Device Name:CD HORIZON Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactAnkit K. Shah
CorrespondentAnkit K. Shah
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 Received2015-12-16
Decision Date2016-02-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169594005 K153589 000
00643169593923 K153589 000
00643169578364 K153589 000
00643169578371 K153589 000
00643169578401 K153589 000
00643169578418 K153589 000
00643169594029 K153589 000
00643169594050 K153589 000
00643169594043 K153589 000
00643169594012 K153589 000

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