FDA 510(k) Application Details - K130438

Device Classification Name	More FDA Info for this Device
510(K) Number	K130438
Device Name	AXLE INTERSPINOUS FUSION SYSTEM
Applicant	X-SPINE SYSTEMS, INC. 452 ALEXANDERSVILLE RD. MIAMISBURG, OH 45342 US Other 510(k) Applications for this Company
Contact	DAVID KIRSCHMAN, M.D. 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	02/21/2013
Decision Date	06/27/2013
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