CD HORIZON SPIRE Z SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

MEDTRONIC SOFAMOR DANEK

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

Pre-market Notification Details

Device IDK123246
510k NumberK123246
Device Name:CD HORIZON SPIRE Z SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactJulie Bassett
CorrespondentJulie Bassett
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeNQP
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-17
Decision Date2012-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169167445 K123246 000

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