FDA 510(k) Application Details - K091406

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K091406
Device Name	Spinal Vertebral Body Replacement Device
Applicant	ATLAS SPINE LLC 1555 JUPITER PARK DR., STE. 4 JUPITER, FL 33458 US Other 510(k) Applications for this Company
Contact	JEANNETTE DAILEY 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	05/12/2009
Decision Date	09/04/2009
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