FDA 510(k) Application Details - K241504

Device Classification Name	More FDA Info for this Device
510(K) Number	K241504
Device Name	iFuse TORQ TNTÖ 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	Jayasri Prabakaran 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	05/28/2024
Decision Date	08/19/2024
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