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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
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