FDA 510(k) Application Details - K243865

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K243865
Device Name	System, Facet Screw Spinal Device
Applicant	Aurora Spine 1930 Palomar Point Way Suite 103 Carlsbad, CA 92009 US Other 510(k) Applications for this Company
Contact	Laszlo Garamszegi Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MRW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2024
Decision Date	03/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review