FDA 510(k) Application Details - K032064

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K032064
Device Name	Spinal Vertebral Body Replacement Device
Applicant	THEKEN SURGICAL,LLC 283 E WATERLOO RD. AKRON, OH 44319 US Other 510(k) Applications for this Company
Contact	TONY PERRY 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	07/03/2003
Decision Date	02/20/2004
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