FDA 510(k) Application Details - K214123

Device Classification Name	More FDA Info for this Device
510(K) Number	K214123
Device Name	T-FIX« 3DSI Joint Fusion System
Applicant	Cutting Edge Spine, LLC 6012 Waxhaw Hwy Mineral Springs, NC 28108 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	12/30/2021
Decision Date	06/24/2022
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