FDA 510(k) Application Details - K063139

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar   More FDA Info for this Device
510(K) Number	K063139
Device Name	Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Applicant	BIOMET SPINE P.O. BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	PATRICIA SANDBORN BERES Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NVR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2006
Decision Date	04/04/2007
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review