FDA 510(k) Application Details - K232149

Device Classification Name	More FDA Info for this Device
510(K) Number	K232149
Device Name	BowTieÖ SI Joint Fusion System
Applicant	SAIL Fusion, LLC 2010 Jimmy Durante Blvd Suite 200 Del Mar, CA 92014 US Other 510(k) Applications for this Company
Contact	Benjamin Arnold 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	07/19/2023
Decision Date	04/20/2024
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