FDA 510(k) Application Details - K161404

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K161404
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	Dave Lamb 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	05/20/2016
Decision Date	07/21/2016
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
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