FDA 510(k) Application Details - K150017

Device Classification Name	More FDA Info for this Device
510(K) Number	K150017
Device Name	SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
Applicant	SpineFrontier, Inc. 500 Cummings Center, Suite 3500 Beverly, MA 01915 US Other 510(k) Applications for this Company
Contact	Manthan J Damani Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2015
Decision Date	04/24/2015
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