FDA 510(k) Application Details - K073105

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar   More FDA Info for this Device
510(K) Number	K073105
Device Name	Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Applicant	INTERBODY INNOVATIONS, LLP 1001 OAKWOOD BLVD. ROUND ROCK, TX 78681 US Other 510(k) Applications for this Company
Contact	J.D. WEBB 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	11/02/2007
Decision Date	01/03/2008
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review