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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 K120978
Device Name OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR
Applicant
MERETE MEDICAL GMBH
102 ALT LANKWITZ
BERLIN,  DE D-12247
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
MERETE MEDICAL GMBH
102 ALT LANKWITZ
BERLIN,  DE D-12247
Correspondent Contact EMMANUEL ANAPLIOTIS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/02/2012
Decision Date 05/02/2012
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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