FDA 510(k) Application Details - K052533

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K052533
Device Name	Spinal Vertebral Body Replacement Device
Applicant	SIGNUS MEDIZINTECHNIK GMBH 4050 OLSON MEMORIAL HWY 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	09/15/2005
Decision Date	11/03/2005
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