FDA 510(k) Application Details - K110063

Device Classification Name	More FDA Info for this Device
510(K) Number	K110063
Device Name	SOVEREIGN SPINAL SYSTEM
Applicant	MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US Other 510(k) Applications for this Company
Contact	MIKE SCOTT Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2011
Decision Date	10/04/2011
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