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 IDK142591
510k NumberK142591
Device Name:CD HORIZON Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactLila Joe
CorrespondentLila Joe
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-15
Decision Date2014-12-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169429062 K142591 000
00643169428836 K142591 000
00643169428560 K142591 000
00643169428614 K142591 000
00643169428645 K142591 000
00643169428676 K142591 000
00643169428720 K142591 000
00643169428751 K142591 000
00643169428775 K142591 000
00643169428812 K142591 000
00643169428898 K142591 000
00643169428928 K142591 000
00643169428959 K142591 000
00643169428607 K142591 000

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