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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K251400
Device Name T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
Applicant
Stryker GmbH
Bohnackerweg 1
Selzach, Solothurn, Ch,  CH 2545
Applicant Contact Jackie Perri
Correspondent
Stryker GmbH
Bohnackerweg 1
Selzach, Solothurn, Ch,  CH 2545
Correspondent Contact Jackie Perri
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received05/06/2025
Decision Date 08/20/2025
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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