FDA 510(k) Application Details - K190230

Device Classification Name	More FDA Info for this Device
510(K) Number	K190230
Device Name	iFuse Implant System«
Applicant	SI-BONE, Inc. 471 El Camino Real, Suite 101 Santa Clara, CA 95050 US Other 510(k) Applications for this Company
Contact	Meirav Harsat 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	02/06/2019
Decision Date	04/03/2019
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