FDA 510(k) Application Details - K173752

Device Classification Name	More FDA Info for this Device
510(K) Number	K173752
Device Name	SI Screw System
Applicant	Zavation Medical Products, LLC 220 Lakeland Parkway Flowood, MS 39232 US Other 510(k) Applications for this Company
Contact	James M. Phillips 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	12/08/2017
Decision Date	03/16/2018
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