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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 K253674
Device Name Blueprint Patient-Specific Instrumentation
Applicant
Stryker Corporation (Tornier, S.A.S.)
161 Rue Lavoisier
Montbonnot-Saint-Martin,  FR 38330
Applicant Contact Aymen Azaiez
Correspondent
Stryker Corporation (Tornier, S.A.S.)
161 Rue Lavoisier
Montbonnot-Saint-Martin,  FR 38330
Correspondent Contact Aymen Azaiez
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
QHE  
Date Received11/21/2025
Decision Date 04/03/2026
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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