MagnetOs Easypack 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 Easypack Putty.

Pre-market Notification Details

Device IDK211201
510k NumberK211201
Device Name:MagnetOs Easypack Putty
ClassificationFiller, Bone Void, Calcium Compound
Applicant Kuros Biosciences B.V. Professor Bronkhorstlaan 10, Building 48 Bilthoven,  NL 3723mb
ContactMarcel Borger
CorrespondentAngela Paterson
Compliance Solutions Ltd Suite 10, Dunswood House, 1 Dunswood Road, Cumbernauld Glasgow,  GB G67 3en
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-22
Decision Date2021-09-02

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