FDA 510(k) Application Details - K123932

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K123932
Device Name	System, Facet Screw Spinal Device
Applicant	X-SPINE SYSTEMS, INC 452 Alexandersville Rd Miamisburg, OH 45342 US Other 510(k) Applications for this Company
Contact	DAVID KIRSCHMAN 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	12/20/2012
Decision Date	05/01/2013
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