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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, Non-Constrained, Metal/Polymer Cemented
510(k) Number K251686
Device Name Tornier Humeral Reconstruction System Max (Tornier HRS Max)
Applicant
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55441
Applicant Contact Stefanie Tarara
Correspondent
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55441
Correspondent Contact Stefanie Tarara
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
HSD   KWS   PHX  
Date Received06/02/2025
Decision Date 10/30/2025
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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