FDA 510(k) Application Details - K082187

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K082187
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	EBI, L.P. 399 JEFFERSON ROAD PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	VIVIAN KELLY MS, RAC 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	08/04/2008
Decision Date	11/13/2008
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