FDA 510(k) Application Details - K251395

Device Classification Name	More FDA Info for this Device
510(K) Number	K251395
Device Name	The RialtoÖ SI Fusion System
Applicant	Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 US Other 510(k) Applications for this Company
Contact	Rong Guo 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	05/05/2025
Decision Date	06/26/2025
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