FDA 510(k) Application Details - K240085

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K240085
Device Name	System, Facet Screw Spinal Device
Applicant	ZygoFix Ltd. 17 Tchelet Street Misgav 2017900 IL Other 510(k) Applications for this Company
Contact	Ofer Levy 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	01/11/2024
Decision Date	04/18/2024
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