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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 K010528
Device Name TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact RICHARD W TREHARNE
Correspondent
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact RICHARD W TREHARNE
Regulation Number878.3300
Classification Product Code
JDK  
Date Received02/23/2001
Decision Date 10/10/2001
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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