CD Horizon™ Fenestrated Screw Set

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™ Fenestrated Screw Set.

Pre-market Notification Details

Device IDK193011
510k NumberK193011
Device Name:CD Horizon™ Fenestrated Screw Set
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactLee Grant
CorrespondentLee Grant
Medtronic 1800 Pyramid Place Memphis,  TN  38132
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-29
Decision Date2020-01-10

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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