FDA 510(k) Application Details - K082112

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K082112
Device Name	Spinal Vertebral Body Replacement Device
Applicant	MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE MEMPHIS, TN 38132 US Other 510(k) Applications for this Company
Contact	MELISA LANSKY Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	MQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2008
Decision Date	08/27/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review