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 IDK152457
510k NumberK152457
Device Name:CD HORIZON Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactLaveeda Leflore
CorrespondentLaveeda Leflore
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 Received2015-08-28
Decision Date2015-10-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169603493 K152457 000
00643169595118 K152457 000
00643169595125 K152457 000
00643169595132 K152457 000
00643169603387 K152457 000
00643169603424 K152457 000
00643169603431 K152457 000
00643169603448 K152457 000
00643169603455 K152457 000
00643169603486 K152457 000
00643169595101 K152457 000

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