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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 K193308
Device Name T2 Alpha Tibia Nailing System, IMN Screws System
Applicant
Stryker Trauma GmbH
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact Sanja Jahr
Correspondent
Stryker Trauma GmbH
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact Sanja Jahr
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received11/29/2019
Decision Date 02/23/2020
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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