FDA 510(k) Application Details - K133245

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K133245
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SOUTH BUILDING THREE, SUITE 600 AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	WILLIAM W SOWERS 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	10/22/2013
Decision Date	10/08/2014
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