SIGNAFUSE Bioactive Bone Graft

Filler, Bone Void, Calcium Compound


The following data is part of a premarket notification filed by Bioventus with the FDA for Signafuse Bioactive Bone Graft.

Pre-market Notification Details

Device IDK193513
510k NumberK193513
Device Name:SIGNAFUSE Bioactive Bone Graft
ClassificationFiller, Bone Void, Calcium Compound
Applicant Bioventus 4721 Emperor Blvd, Suite 100 Durham,  NC  27703
ContactKim Patterson Kelly
CorrespondentChristine Scifert
MRC-X, LLC 6075 Poplar Ave Memphis,  TN  38119
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-19
Decision Date2020-06-18

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