FDA 510(k) Application Details - K232348

Device Classification Name	More FDA Info for this Device
510(K) Number	K232348
Device Name	RIGELÖ 3DR Standalone Anterior Cervical Interbody Fusion System
Applicant	MiRus, LLC 1755 West Oak Parkway, Suite 100 Marietta, GA 30062 US Other 510(k) Applications for this Company
Contact	Jordan Bauman 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	08/07/2023
Decision Date	10/27/2023
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