FDA 510(k) Application Details - K010378

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K010378
Device Name	Spinal Vertebral Body Replacement Device
Applicant	IMPLEX CORP. 80 COMMERCE DR. ALLENDALE, NJ 07401-1600 US Other 510(k) Applications for this Company
Contact	JOHN SCHALAGO 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	02/08/2001
Decision Date	01/28/2002
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