FDA 510(k) Application Details - K212498

Device Classification Name	More FDA Info for this Device
510(K) Number	K212498
Device Name	Stable-L Standalone Lumbar Interbody System
Applicant	Nexus Spine, LLC 2825 East Cottonwood Parkway Suite 330 Salt Lake City, UT 84121 US Other 510(k) Applications for this Company
Contact	Jared Crocker 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	08/09/2021
Decision Date	03/18/2022
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