FDA 510(k) Application Details - K181881

Device Classification Name	More FDA Info for this Device
510(K) Number	K181881
Device Name	Outlet Sacroiliac Joint Fusion System
Applicant	SIJ Surgical 6829 Falls of Neuse Rd., Ste 103 Raleigh, NC 27615 US Other 510(k) Applications for this Company
Contact	Daniel Hoehn 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	07/13/2018
Decision Date	10/03/2018
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