FDA 510(k) Application Details - K124014

Device Classification Name	More FDA Info for this Device
510(K) Number	K124014
Device Name	SUREFIX INTERSPINOUS FUSION SYSTEM
Applicant	JG SPINE, LLC 100 E. SOUTH MAIN ST. WAXHAW, NC 28173 US Other 510(k) Applications for this Company
Contact	JOHN KAPITAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2012
Decision Date	08/09/2013
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