CERAMENT G

Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

BoneSupport AB

The following data is part of a De Novo classification by Bonesupport Ab with the FDA for Cerament G.

Pre-market Notification Details

DeNovo IDDEN210044
Device Name:CERAMENT G
ClassificationFiller, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
Applicant BoneSupport AB scheelevagen 19, Ideon Science Park Lund,  SE Se 223-70
ContactBlerta Shuka
Product CodeQRR  
CFR Regulation Number888.3046 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardOrthopedic
Classification AdvisoryOrthopedic
TypeDirect
Date Received2021-09-28
Decision Date2022-05-17
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07350055430387 DEN210044 000

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