FDA 510(k) Application Details - K143547

Device Classification Name	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)   More FDA Info for this Device
510(K) Number	K143547
Device Name	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Applicant	VIVORTE, INC 1044 EAST CHESTNUT STREET LOUISVILLE, KY 40204 US Other 510(k) Applications for this Company
Contact	Robert Burden Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	MBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2014
Decision Date	01/14/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review