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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Cement Restrictor
510(k) Number K013663
Device Name CEMENT RESTRICTOR
Applicant
Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact RICHARD W TREHARNE
Correspondent
Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact RICHARD W TREHARNE
Regulation Number878.3300
Classification Product Code
JDK  
Date Received11/06/2001
Decision Date 12/05/2001
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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