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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spine, Plate, Laminoplasty, Metal
510(k) Number K050082
Device Name CENTERPIECE PLATE FIXATION SYSTEM
Applicant
Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact RICHARD W TREHARNE, PHD.
Correspondent
Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact RICHARD W TREHARNE, PHD.
Regulation Number888.3050
Classification Product Code
NQW  
Date Received01/13/2005
Decision Date 06/06/2005
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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