FDA 510(k) Application Details - K161438

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K161438
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	GENESYS SPINE 1250 CAPITAL OF TEXAS OF HIGHWAY SOUTH, BUILDING 3 SUITE 600 AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	BRIAN BERGERON Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2016
Decision Date	11/08/2016
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