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 IDK182119
510k NumberK182119
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
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-06
Decision Date2018-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000048266 K182119 000
00763000048235 K182119 000
00763000048204 K182119 000
00763000048174 K182119 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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