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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K043020
Device Name GLAXY 3.2 SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Applicant Contact RICHARD TREHARNE
Correspondent
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Correspondent Contact RICHARD TREHARNE
Regulation Number888.3050
Classification Product Code
KWP  
Date Received11/03/2004
Decision Date 01/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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