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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 K252788
Device Name Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)
Applicant
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Applicant Contact Lamia Askri
Correspondent
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Correspondent Contact Lamia Askri
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received09/02/2025
Decision Date 01/08/2026
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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