MagnetOs Putty

Filler, Bone Void, Calcium Compound

Kuros Biosciences B.V.

The following data is part of a premarket notification filed by Kuros Biosciences B.v. with the FDA for Magnetos Putty.

Pre-market Notification Details

Device IDK171563
510k NumberK171563
Device Name:MagnetOs Putty
ClassificationFiller, Bone Void, Calcium Compound
Applicant Kuros Biosciences B.V. Professor Bronkhorstlaan 10, Building 48 Bilthoven,  NL 3723mb
ContactYvonne P. Bovell
CorrespondentYvonne P. Bovell
Kuros Biosciences B.V. Professor Bronkhorstlaan 10, Building 48 Bilthoven,  NL 3723mb
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-30
Decision Date2017-08-24
Summary:summary

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