FDA 510(k) Application Details - K131521

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K131521
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	SPINECRAFT LLC 777 OAKMONT LANE WESTMONT, IL 60559 US Other 510(k) Applications for this Company
Contact	AMI AKALLAL-ASAAD Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2013
Decision Date	12/24/2013
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