FDA 510(k) Application Details - K212853

Device Classification Name	More FDA Info for this Device
510(K) Number	K212853
Device Name	Cervical Stand-Alone System
Applicant	Eminent Spine, LLC 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	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2021
Decision Date	11/05/2021
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