FDA 510(k) Application Details - K192018

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K192018
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	Titan Spine, Inc 6140 West Executive Dr., Suite A Mequon, WI 53092 US Other 510(k) Applications for this Company
Contact	Jane Rodd 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	07/29/2019
Decision Date	08/16/2019
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
Expedited Review