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 IDK201407
510k NumberK201407
Device Name:CD Horizon™ Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis,  TN  38132
ContactUsman Rashid
CorrespondentRaphael Mcinnis
Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis,  TN  38132
Product CodeNKB  
Subsequent Product CodeHBE
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeOLO
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-28
Decision Date2020-09-10

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