FDA 510(k) Application Details - K242527

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K242527
Device Name	System, Facet Screw Spinal Device
Applicant	Spinal Elements Inc 3115 S. Melrose Suite 200 Carlsbad, CA 92010 US Other 510(k) Applications for this Company
Contact	Cheryl Allen 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	08/26/2024
Decision Date	05/21/2025
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