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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K250338
Device Name MSS - Humeral reverse liners extension
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro,  CH 6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
6386 Global Drive, Suite 101
Memphis,  TN  38141
Correspondent Contact Christopher Lussier
Regulation Number888.3660
Classification Product Code
PHX  
Date Received02/06/2025
Decision Date 10/31/2025
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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