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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 K173794
Device Name AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
Applicant
Medacta International SA
Strada Regina
Castel San Pietro,  CH Ch-6874
Applicant Contact Stefano Baj
Correspondent
Mapi USA, Inc.
2343 Alexandria Drive, Suite 100
Lexington,  KY  40504
Correspondent Contact Elizabeth Rose
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LPH   LZY   MEH  
Date Received12/14/2017
Decision Date 03/14/2018
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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