FDA 510(k) Application Details - K101765

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K101765
Device Name	System, Facet Screw Spinal Device
Applicant	MEDTRONIC SPINE LLC. 1221 CROSSMAN AVE. SUNNYVALE, CA 94089 US Other 510(k) Applications for this Company
Contact	ERICA HOFFMAN 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	06/23/2010
Decision Date	10/22/2010
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