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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 K161753
Device Name Hoffman LRF System
Applicant
STRYKER GMBH
325 CORPORATE DRIVE
MAHWAH,  NJ  07430
Applicant Contact PAUL NELSON
Correspondent
STRYKER GMBH
Bohnackerweg 1
Selzach,  CH CH-2545
Correspondent Contact PAUL NELSON
Regulation Number888.3030
Classification Product Code
KTT  
Date Received06/24/2016
Decision Date 11/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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