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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 K131458
Device Name MPACT DM LINER CONVERTER
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 Received05/20/2013
Decision Date 10/01/2013
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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