FDA 510(k) Application Details - K231715

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K231715
Device Name	Appliance, Fixation, Spinal Intervertebral Body
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	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2023
Decision Date	01/26/2024
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