FDA 510(k) Application Details - K081548

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K081548
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	SCIENT'X USA, INC. 1015 MAITLAND CENTER COMMONS SUITE 106A MAITLAND, FL 32751 US Other 510(k) Applications for this Company
Contact	JOHN SANDERS 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	06/02/2008
Decision Date	01/29/2009
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