FDA 510(k) Application Details - K223521

Device Classification Name	More FDA Info for this Device
510(K) Number	K223521
Device Name	ZESPIN SI Joint Fusion System
Applicant	Aegis Spine, Inc. 9781 S. Meridian Blvd, Ste 300 Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	KiHyang Kim 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	11/23/2022
Decision Date	01/20/2023
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