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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, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K122911
Device Name VERSAFITCUP CC TRIO EXTENSION
Applicant
Medacta International
4725 Calle Quetzal Unit B
Camarillo,  CA  93012
Applicant Contact ADAM GROSS
Correspondent
Medacta International
4725 Calle Quetzal Unit B
Camarillo,  CA  93012
Correspondent Contact ADAM GROSS
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received09/21/2012
Decision Date 10/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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