FDA 510(k) Application Details - K213959

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K213959
Device Name	Filler, Bone Void, Calcium Compound
Applicant	Kuros Biosciences BV Professor Bronkhorstlaan 10, building 48 Bilthoven 3723 MB NL Other 510(k) Applications for this Company
Contact	Sonja van der Meer Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	MQV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2021
Decision Date	04/14/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review