FDA 510(k) Application Details - K093127

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K093127
Device Name	Spinal Vertebral Body Replacement Device
Applicant	ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	KATHLEEN RUTHERFORD 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	10/02/2009
Decision Date	03/04/2010
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