FDA 510(k) Application Details - K201979

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K201979
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	Eminent Spine, LLC 1705 Ohio Drive, Suite 300 Plano, TX 75093 US Other 510(k) Applications for this Company
Contact	Stephen Courtney 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	07/16/2020
Decision Date	08/25/2020
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