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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K130334
Device Name HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)
Applicant
Stryker Trauma AG
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact ESTELA CELI
Correspondent
Stryker Trauma AG
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact ESTELA CELI
Regulation Number888.3030
Classification Product Code
KTT  
Date Received02/11/2013
Decision Date 05/03/2013
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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