ARCHITEX SPACE MAINTENANCE SYSTEM

Plate, Bone

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 Architex Space Maintenance System.

Pre-market Notification Details

Device IDK110259
510k NumberK110259
Device Name:ARCHITEX SPACE MAINTENANCE SYSTEM
ClassificationPlate, Bone
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactKelly Davidson
CorrespondentKelly Davidson
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-28
Decision Date2011-04-13
Summary:summary

NIH GUDID Devices

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