FDA 510(k) Application Details - K221399

Device Classification Name	More FDA Info for this Device
510(K) Number	K221399
Device Name	ZIPÖ MIS Interspinous Fusion System
Applicant	Aurora Spine, Inc. 1930 Palomar Point Way, Suite #103 Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Laszlo Garamszegi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2022
Decision Date	07/08/2022
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