FDA 510(k) Application Details - K181342

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K181342
Device Name	Filler, Bone Void, Calcium Compound
Applicant	AgNovos Healthcare USA, LLC 7301 Calhoun Place, Suite 100 Rockville, MD 20855 US Other 510(k) Applications for this Company
Contact	Felipe Aguel 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	05/21/2018
Decision Date	07/19/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review