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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 K113303
Device Name OSLEOBRIDGE IDSF SPACER CONECTOR
Original Applicant
MERETE MEDICAL GMBH
102 alt lankwitz
berlin,  DE d-12247
Original Contact emmanuel anapliois
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/09/2011
Decision Date 12/09/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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