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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K142648
Device Name SPINEDESIGN Spine Surgery Planning (Software Application)
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Applicant Contact Lila Joe
Correspondent
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Correspondent Contact LILA JOE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/17/2014
Decision Date 05/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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