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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 K254128
Device Name InSet Reverse Total Shoulder System
Applicant
Shoulder Innovations, Inc.
1535 Steele Ave. SW
Suite B
Grand Rapids,  MI  49507
Applicant Contact Mark D. Hanes
Correspondent
Shoulder Innovations, Inc.
1535 Steele Ave. SW
Suite B
Grand Rapids,  MI  49507
Correspondent Contact Mark D. Hanes
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
MBF  
Date Received12/22/2025
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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