FDA 510(k) Application Details - K150875

Device Classification Name	More FDA Info for this Device
510(K) Number	K150875
Device Name	iFuse Implant System
Applicant	SI-BONE, Inc. 3055 Olin Avenue, Suite 2200 San Jose, CA 95128 US Other 510(k) Applications for this Company
Contact	Roxanne Dubois 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	04/01/2015
Decision Date	07/22/2015
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