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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
Medacta International SA
Strada Regina
Castel San Pietro,  CH ch-6874
Applicant Contact Stefano Baj
Mapi USA, Inc.
2343 Alexandria Drive, Suite 100
Lexington,  KY  40504
Correspondent Contact Elizabeth Rose
Regulation Number888.3040
Classification Product Code
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