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 IDK173249
510k NumberK173249
Device Name:CD HORIZON™ Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Pl Memphis,  TN  38132
ContactAnkit K. Shah
CorrespondentAnkit K. Shah
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Pl Memphis,  TN  38132
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-10
Decision Date2018-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169754638 K173249 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.