FDA 510(k) Application Details - K222572

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K222572
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	Dio Medical Corporation 2100 Campus Lane, Suite 100 East Norriton, PA 19403 US Other 510(k) Applications for this Company
Contact	Milan George 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	08/25/2022
Decision Date	10/18/2022
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