CD Horizon™ Spinal System

Posterior Metal/polymer Spinal System, Fusion

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 IDK182928
510k NumberK182928
Device Name:CD Horizon™ Spinal System
ClassificationPosterior Metal/polymer Spinal System, Fusion
Applicant Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactRaphael Mcinnis
CorrespondentRaphael Mcinnis
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
Product CodeNQP  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeNKB
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-22
Decision Date2019-01-11
Summary:summary

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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