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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
Applicant
MERETE MEDICAL GMBH
102 ALT LANKWITZ
BERLIN,  DE D-12247
Applicant Contact EMMANUEL ANAPLIOIS
Correspondent
MERETE MEDICAL GMBH
102 ALT LANKWITZ
BERLIN,  DE D-12247
Correspondent 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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