CD HORIZON Spinal System

Thoracolumbosacral Pedicle Screw System

The following data is part of a premarket notification filed by Medtronic Sofamor Danck Usa, Inc. with the FDA for Cd Horizon Spinal System.

Device ID	K142847
510k Number	K142847
Device Name:	CD HORIZON Spinal System
Classification	Thoracolumbosacral Pedicle Screw System
Applicant	MEDTRONIC SOFAMOR DANCK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
Contact	Laveeda Leflore
Correspondent	Laveeda Leflore MEDTRONIC SOFAMOR DANCK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
Product Code	NKB
Subsequent Product Code	KWP
Subsequent Product Code	KWQ
Subsequent Product Code	MNH
Subsequent Product Code	MNI
Subsequent Product Code	OSH
CFR Regulation Number	888.3070 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2014-09-30
Decision Date	2014-10-27
Summary:	summary