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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Augmented Reality
510(k) Number K251737
Device Name NextAR(TM) Shoulder Platform
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro,  CH CH 6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
6386 Global Dr.
Suite 101
Memphis,  TN  38141
Correspondent Contact Christopher Lussier
Regulation Number882.4560
Classification Product Code
SBF  
Date Received06/06/2025
Decision Date 09/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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