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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 K260102
Device Name Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
Applicant
Stryker Corporation (Tornier, Inc.)
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Applicant Contact Jang Long
Correspondent
Stryker Corporation (Tornier, Inc.)
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Correspondent Contact Jang Long
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received01/13/2026
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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