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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 K191271
Device Name T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
Applicant
Stryker Trauma GmbH
Prof-Kuentscher-Str. 1-5
Schoenkirchen,  DE 24232
Applicant Contact Heike Gustke
Correspondent
Stryker Trauma GmbH
Prof-Kuentscher-Str. 1-5
Schoenkirchen,  DE 24232
Correspondent Contact Heike Gustke
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received05/13/2019
Decision Date 06/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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