FDA 510(k) Application Details - K161859

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K161859
Device Name	Filler, Bone Void, Calcium Compound
Applicant	XPAND BIOTECHNOLOGY BV PROFESSOR BRONKHORSTLAAN 10D, BUILDING 48 BILTHOVEN 3723 MB NL Other 510(k) Applications for this Company
Contact	YVONNE P. BOVELL 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	07/06/2016
Decision Date	02/24/2017
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