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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 K153377
Device Name Hoffmann LRF (Limb Reconstruction Frame) System
Stryker GmbH
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Paul Nelson
Stryker GmbH
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Paul Nelson
Regulation Number888.3030
Classification Product Code
Date Received11/23/2015
Decision Date 04/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls