FDA 510(k) Application Details - K992012

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K992012
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	ADVANCED SPINE FIXATION SYSTEMS, INC. 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND 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	06/15/1999
Decision Date	02/04/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review