FDA 510(k) Application Details - K111553

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K111553
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	SPINEFRONTIER, INC. 500 CUMMINGS CENTER, STE. 3500 BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	HANNAH CROWE 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	06/03/2011
Decision Date	09/28/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review