FDA 510(k) Application Details - K092568

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K092568
Device Name	System, Facet Screw Spinal Device
Applicant	AMENDIA, INC. 13540 GUILD AVENUE APPLE VALLEY, MN 55124 US Other 510(k) Applications for this Company
Contact	RICHARD JANSEN 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	08/20/2009
Decision Date	11/17/2009
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