VANTAGE ANTERIOR FIXATION SYSTEM

Appliance, Fixation, Spinal Interlaminal

MEDTRONIC SOFAMOR DANEK, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Vantage Anterior Fixation System.

Pre-market Notification Details

Device IDK031533
510k NumberK031533
Device Name:VANTAGE ANTERIOR FIXATION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard Treharne
CorrespondentRichard Treharne
MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-16
Decision Date2003-06-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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