FDA 510(k) Application Details - K080024

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K080024
Device Name	Spinal Vertebral Body Replacement Device
Applicant	K2M, INC. 751 MILLER DR. SE, SUITE F1 LEESBURG, VA 20175 US Other 510(k) Applications for this Company
Contact	RICHARD W WOODS 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	01/04/2008
Decision Date	01/24/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review