FDA 510(k) Application Details - K213641

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K213641
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	CTL Medical Corporation 4550 Excel Pkwy Ste 300 Addison, TX 75001 US Other 510(k) Applications for this Company
Contact	Sean Suh 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	11/18/2021
Decision Date	09/15/2022
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