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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 K203819
Device Name T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System
Applicant
Stryker GmbH
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Jemin Dedania
Correspondent
Stryker GmbH
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Jemin Dedania
Regulation Number888.3020
Classification Product Code
HSB  
Date Received12/29/2020
Decision Date 02/26/2021
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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