Cerament Bone Void Filler

Filler, Bone Void, Calcium Compound

BoneSupport AB

The following data is part of a premarket notification filed by Bonesupport Ab with the FDA for Cerament Bone Void Filler.

Pre-market Notification Details

Device IDK201535
510k NumberK201535
Device Name:Cerament Bone Void Filler
ClassificationFiller, Bone Void, Calcium Compound
Applicant BoneSupport AB Scheelevagen 19, Ideon Science Park Lund,  SE Se 223-70
ContactBlerta Shuka
CorrespondentBlerta Shuka
BoneSupport AB Scheelevagen 19, Ideon Science Park Lund,  SE Se 223-70
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2020-10-16

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