FDA 510(k) Application Details - K223819

Device Classification Name	More FDA Info for this Device
510(K) Number	K223819
Device Name	SI-Cure Sacroiliac Joint Fusion System
Applicant	Alevio, LLC 200 Cahaba Park, Suite 100 Birmingham, AL 35242 US Other 510(k) Applications for this Company
Contact	Trey Robbins 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	12/21/2022
Decision Date	01/18/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review