MODIFICATION TO: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 Modification To:cd Horizon Spinal System.

Pre-market Notification Details

Device IDK092325
510k NumberK092325
Device Name:MODIFICATION TO:CD HORIZON SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactBrad Sheals
CorrespondentBrad Sheals
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 CodeNQP
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-04
Decision Date2009-12-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169167407 K092325 000
00643169167391 K092325 000

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