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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/Polymer, Porous Uncemented
510(k) Number K103721
Device Name MPACT ACETABULAR SYSTEM
Applicant
Medacta International
13721 Via Tres Vista
San Diego,  CA  92129
Applicant Contact NATALIE J KENNEL
Correspondent
Medacta International
13721 Via Tres Vista
San Diego,  CA  92129
Correspondent Contact NATALIE J KENNEL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received12/21/2010
Decision Date 03/21/2011
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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