FDA 510(k) Application Details - K073530

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K073530
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	ACCELERATED INNOVATION, LLC 1033 US HIGHWAY 46 EAST SUITE A204 CLIFTON, NJ 07013 US Other 510(k) Applications for this Company
Contact	MICHAEL KVITNITSKY Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2007
Decision Date	01/31/2008
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