FDA 510(k) Application Details - K052096

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K052096
Device Name	Spinal Vertebral Body Replacement Device
Applicant	SIGNUS MEDICAL LLC. 4050 OLSON MEMORIAL HIGHWAY SUITE 350 MINNEAPOLIS, MN 55422 US Other 510(k) Applications for this Company
Contact	TRACY L GRAY 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	08/03/2005
Decision Date	08/16/2005
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