FDA 510(k) Application Details - K983667

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K983667
Device Name	Spinal Vertebral Body Replacement Device
Applicant	IONICS MEDICAL CORP. 702 13TH ST., #108 MIAMI BEACH, FL 33139 US Other 510(k) Applications for this Company
Contact	M. LAINE MASHBURN 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	10/19/1998
Decision Date	07/05/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review