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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 K241292
Device Name MyShoulder Planner (5.3SSWPL)
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 Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
LLZ   QHE  
Date Received05/08/2024
Decision Date 01/30/2025
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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