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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 K252404
Device Name Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
Applicant
Biomet Orthopedics
56 E. Bell Dr.
Warsaw,  IN  46580
Applicant Contact Julie Gantenberg
Correspondent
Biomet Orthopedics
56 E. Bell Dr.
Warsaw,  IN  46580
Correspondent Contact Julie Gantenberg
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received07/31/2025
Decision Date 04/15/2026
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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