FDA 510(k) Application Details - K132479

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K132479
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	INTERVENTIONAL SPINE, INC. 13700 ALTON PKWY., SUITE 160 IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	JANE METCALF Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2013
Decision Date	09/19/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review