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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 K192126
Device Name AMIStem-P Short Neck
Applicant
Medacta International SA
Strada Regina
Castel San Pietro,  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
3973 Delp Street
Memphis,  TN  38118
Correspondent Contact Chris Lussier
Regulation Number888.3353
Classification Product Code
LZO  
Date Received08/06/2019
Decision Date 11/22/2019
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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