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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 K181026
Device Name OsteoBridge™ IDSF System
Merete GmbH
Alt-Lankwitz 102
Berlin,  DE 12247
Applicant Contact Paul Munch
Merete GmbH
Alt-Lankwitz 102
Berlin,  DE 12247
Correspondent Contact Paul Munch
Regulation Number888.3020
Classification Product Code
Date Received04/18/2018
Decision Date 10/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls