FDA 510(k) Application Details - K003709

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K003709
Device Name	Spinal Vertebral Body Replacement Device
Applicant	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. NORWALK, CT 06856 US Other 510(k) Applications for this Company
Contact	JENNIFER E SCHUCK 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	12/01/2000
Decision Date	07/18/2001
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