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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, shoulder, semi-constrained, metal/polymer cemented
510(k) Number K170910
Device Name Medacta Anatomic Shoulder Prosthesis
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 Roshana Ahmed, M.A., RAC
Regulation Number888.3660
Classification Product Code
KWS  
Date Received03/28/2017
Decision Date 08/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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