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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
Applicant
Merete GmbH
Alt-Lankwitz 102
Berlin,  DE 12247
Applicant Contact Paul Munch
Correspondent
Merete GmbH
Alt-Lankwitz 102
Berlin,  DE 12247
Correspondent Contact Paul Munch
Regulation Number888.3020
Classification Product Code
HSB  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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