FDA 510(k) Application Details - K003928

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K003928
Device Name	System, Facet Screw Spinal Device
Applicant	MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US Other 510(k) Applications for this Company
Contact	RICHARD W TREHARNE 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	12/20/2000
Decision Date	01/17/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review