FDA 510(k) Application Details - K221936

Device Classification Name	More FDA Info for this Device
510(K) Number	K221936
Device Name	Standalone ALIF Interbody Fusion System
Applicant	Eminent Spine 2004 Ventura Drive Suite 100 Plano, TX 75093 US Other 510(k) Applications for this Company
Contact	Stephen Courtney 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	07/01/2022
Decision Date	10/17/2022
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