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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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