MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Pyramid Anterior Plate Fixation System.

Pre-market Notification Details

Device IDK021226
510k NumberK021226
Device Name:MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard Treharne
CorrespondentRichard Treharne
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-18
Decision Date2002-05-13
Summary:summary

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