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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 K193175
Device Name Lateralized Glenosphere
Applicant
Medacta Inernational SA
Strada Regina
Castel San Pietro (Ch),  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
3973 Delp St.
Memphis,  TN  38118
Correspondent Contact Chris Lussier
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   MBF  
Date Received11/18/2019
Decision Date 08/11/2020
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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