FDA 510(k) Application Details - K111792

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K111792
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	SIGNUS MEDIZINTECHNIK GMBH 8202 SHERMAN ROAD CHESTERLAND, OH 44026-2141 US Other 510(k) Applications for this Company
Contact	KAREN E WARDEN, PHD 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	06/27/2011
Decision Date	03/05/2012
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