CD Horizon™ Spinal System

Thoracolumbosacral Pedicle Screw System

Medtronic

The following data is part of a premarket notification filed by Medtronic with the FDA for Cd Horizon™ Spinal System.

Pre-market Notification Details

Device IDK210637
510k NumberK210637
Device Name:CD Horizon™ Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Medtronic 1800 Pyramid Place Memphis,  TN  38132
ContactShweta Sharma
CorrespondentShweta Sharma
Medtronic 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 Received2021-03-03
Decision Date2021-04-30

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

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.