FDA 510(k) Application Details - K191581

Device Classification Name	More FDA Info for this Device
510(K) Number	K191581
Device Name	Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
Applicant	Titan Spine, Inc 6140 W. Executive Dr., Suite A Mequon, WI 53092 US Other 510(k) Applications for this Company
Contact	Kelly McDonnell Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2019
Decision Date	01/08/2020
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