FDA 510(k) Application Details - K241813

Device Classification Name	More FDA Info for this Device
510(K) Number	K241813
Device Name	SI-TECHNOLOGY« SI-DESIS« XÖ Sacroiliac Joint Fusion System
Applicant	SI-Technology, LLC 320 East Vine Drive, Suite 217 Fort Collins, CO 80524 US Other 510(k) Applications for this Company
Contact	Donner Chris 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	06/21/2024
Decision Date	08/13/2024
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