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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 K253640
Device Name T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
Applicant
Stryker GmbH
Bohnackerweg 1
Selzach, Solothurn, Ch,  CH 2545
Applicant Contact Ileana Freige
Correspondent
Stryker GmbH
Bohnackerweg 1
Selzach, Solothurn, Ch,  CH 2545
Correspondent Contact Ileana Freige
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Codes
HRS   HWC  
Date Received11/19/2025
Decision Date 02/03/2026
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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