FDA 510(k) Application Details - K220441

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K220441
Device Name	Appliance, Fixation, Spinal Intervertebral Body
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	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	02/16/2022
Decision Date	09/16/2022
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