FDA 510(k) Application Details - K150812

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K150812
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	Genesys Spine 1250 Capital of Texas Highway Building Three 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	ODP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2015
Decision Date	09/03/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review