FDA 510(k) Application Details - K230840

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K230840
Device Name	System, Facet Screw Spinal Device
Applicant	Providence Medical Technology, Inc 4234 Hacienda Drive, Suite 150 Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Edward Liou 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	03/27/2023
Decision Date	12/19/2023
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