FDA 510(k) Application Details - K163621

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K163621
Device Name	Filler, Bone Void, Calcium Compound
Applicant	Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	John Rossman 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	12/22/2016
Decision Date	05/02/2017
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