Synthetic Bone Putty

Filler, Bone Void, Calcium Compound

Ventris Medical

The following data is part of a premarket notification filed by Ventris Medical with the FDA for Synthetic Bone Putty.

Pre-market Notification Details

Device IDK221644
510k NumberK221644
Device Name:Synthetic Bone Putty
ClassificationFiller, Bone Void, Calcium Compound
Applicant Ventris Medical 1201 Dove Street, Suite 470 Newport Beach,  CA  92660
ContactJohn Brunelle
CorrespondentJohn Brunelle
Ventris Medical 1201 Dove Street, Suite 470 Newport Beach,  CA  92660
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-06
Decision Date2022-09-02

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