FDA 510(k) Application Details - K190025

Device Classification Name	More FDA Info for this Device
510(K) Number	K190025
Device Name	EVOL« -SI Joint Fusion System
Applicant	Cutting Edge Spine, LLC 101 Waxhaw Professional Park, Suite A Waxhaw, NC 28173 US Other 510(k) Applications for this Company
Contact	Kyle Kuntz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/07/2019
Decision Date	08/12/2019
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