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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name filler, bone void, calcium compound containing single approved aminoglycoside
De Novo Number DEN210044
Device Name CERAMENT G
BoneSupport AB
scheelevagen 19, ideon science park
lund,  SE se 223-70
Contact blerta shuka
Regulation Number888.3046
Classification Product Code
Date Received09/28/2021
Decision Date 05/17/2022
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Reclassification Order Reclassification Order
Type Direct