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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 K212428
Device Name Centerpiece Plate Fixation System
Applicant
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact Diamond Wallace
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Diamond Wallace
Regulation Number888.3050
Classification Product Code
NQW  
Date Received08/04/2021
Decision Date 12/13/2021
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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