FDA 510(k) Application Details - K172484

Device Classification Name	More FDA Info for this Device
510(K) Number	K172484
Device Name	A-CIFT SoloFuse
Applicant	SpineFrontier, Inc. 350 Main Street 3rd Floor Malden, MA 02148 US Other 510(k) Applications for this Company
Contact	Vito Lore Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2017
Decision Date	05/08/2018
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