FDA 510(k) Application Details - K171567

Device Classification Name	More FDA Info for this Device
510(K) Number	K171567
Device Name	IRIX-A Lumbar Integrated Fusion System
Applicant	X-Spine Systems, Inc. 452 Alexanderville Rd. Miamisburg, OH 45342 US Other 510(k) Applications for this Company
Contact	Kriss Andersson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2017
Decision Date	08/28/2017
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