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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 K112059
Device Name T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
Applicant
Stryker
325 corporate drive
mahwah,  NJ  07430
Applicant Contact valerie giambanco
Correspondent
Stryker
325 corporate drive
mahwah,  NJ  07430
Correspondent Contact valerie giambanco
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/19/2011
Decision Date 08/08/2011
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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