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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K171640
Device Name M-ARS ACL: Anatomic Ribbon Surgery System
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 Number888.3040
Classification Product Code
MBI  
Date Received06/02/2017
Decision Date 10/23/2017
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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