MagnetOs Flex Matrix

Filler, Bone Void, Calcium Compound

Kuros Biosciences BV

The following data is part of a premarket notification filed by Kuros Biosciences Bv with the FDA for Magnetos Flex Matrix.

Pre-market Notification Details

Device IDK213959
510k NumberK213959
Device Name:MagnetOs Flex Matrix
ClassificationFiller, Bone Void, Calcium Compound
Applicant Kuros Biosciences BV Professor Bronkhorstlaan 10, Building 48 Bilthoven,  NL 3723 Mb
ContactSonja Van Der Meer
CorrespondentSonja Van Der Meer
Kuros Biosciences BV Professor Bronkhorstlaan 10, Building 48 Bilthoven,  NL 3723 Mb
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-17
Decision Date2022-04-14

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