FDA 510(k) Application Details - K181347

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K181347
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Osseus Fusion Systems, LLC 2703 Mockingbird Lane, Suite 102 Dallas, TX 75235 US Other 510(k) Applications for this Company
Contact	Robert Pace 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	05/21/2018
Decision Date	08/15/2018
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