OsOpia Synthetic Bone Void Filler

Bone Grafting Material, Synthetic

RevisiOs BV

The following data is part of a premarket notification filed by Revisios Bv with the FDA for Osopia Synthetic Bone Void Filler.

Pre-market Notification Details

Device IDK201546
510k NumberK201546
Device Name:OsOpia Synthetic Bone Void Filler
ClassificationBone Grafting Material, Synthetic
Applicant RevisiOs BV Professor Bronkhorstlaan 10, Building 48 3723 Mb Bilthoven,  NL
ContactHen Baron
CorrespondentKathy Remsen
MRC Global 9085 East Mineral Circle, Suite 110 Centennial,  CO  80112
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-09
Decision Date2020-10-02

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