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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, Uncemented
510(k) Number K253592
Device Name Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
Applicant
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46850
Applicant Contact Alexandria Irwin
Correspondent
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46850
Correspondent Contact Alexandria Irwin
Regulation Number888.3670
Classification Product Code
MBF  
Subsequent Product Codes
HSD   KWS   KWT   PHX  
Date Received11/17/2025
Decision Date 04/13/2026
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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