FDA 510(k) Application Details - K222512

Device Classification Name	More FDA Info for this Device
510(K) Number	K222512
Device Name	Integrity-SI Fusion System
Applicant	OsteoCentric Technologies 75 West 300 North Suite 150 Logan, UT 84321 US Other 510(k) Applications for this Company
Contact	Todd Evans 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	08/19/2022
Decision Date	09/12/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review