FDA 510(k) Application Details - K222448

Device Classification Name	More FDA Info for this Device
510(K) Number	K222448
Device Name	UNITY Sacroiliac Joint Fixation System
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	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2022
Decision Date	10/13/2022
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