FDA 510(k) Application Details - K102957

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K102957
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	CUTTING EDGE SPINE, LLC 100 E. SOUTH MAIN STREET PO BOX 1458 MATTHEWS, NC 28173 US Other 510(k) Applications for this Company
Contact	JOHN KAPITAN 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	10/05/2010
Decision Date	04/28/2011
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