FDA 510(k) Application Details - K182322

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K182322
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Spineology Inc 7800 Third Street N., Suite 600 St. Paul, MN 55128 US Other 510(k) Applications for this Company
Contact	Karen Roche 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	08/27/2018
Decision Date	10/24/2018
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