FDA 510(k) Application Details - K001794

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K001794
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	JON CAPAROTTA 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	06/14/2000
Decision Date	07/12/2000
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Special
Reviewed By Third Party	N
Expedited Review