FDA 510(k) Application Details - K071420

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K071420
Device Name	System, Facet Screw Spinal Device
Applicant	SPINEFRONTIER, INC. 100 CUMMINGS CENTER SUITE 240C BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	THOMAS CARLSON Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MRW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2007
Decision Date	01/16/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review