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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K171595
Device Name M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro (Ch),  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Mapi USA, Inc.
2343 Alexandria Dr., Suite 100
Lexington,  KY  40504
Correspondent Contact Elizabeth Rose, MST, RAC
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Codes
HTN   HWC  
Date Received05/31/2017
Decision Date 08/02/2017
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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