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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sacroiliac joint fixation
510(k) Number K173752
Device Name SI Screw System
Applicant
Zavation Medical Products, LLC
220 Lakeland Parkway
Flowood,  MS  39232
Applicant Contact James M. Phillips
Correspondent
Zavation Medical Products, LLC
220 Lakeland Parkway
Flowood,  MS  39232
Correspondent Contact Milton Phillips
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Code
HWC  
Date Received12/08/2017
Decision Date 03/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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