FDA 510(k) Application Details - K122008

Device Classification Name	More FDA Info for this Device
510(K) Number	K122008
Device Name	INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
Applicant	INCITE INNOVATION LLC 1500 MAIN STREET STE. 2410 SPRINGFIELD, MA 01115 US Other 510(k) Applications for this Company
Contact	JOHN KIRWAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2012
Decision Date	11/16/2012
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