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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Manual)
510(k) Number K162884
Device Name SpineGuard DSG Zavation Screw System
Applicant
Spineguard S.A.
10 Cours Louis Lumiere
Vincennes,  FR 94300
Applicant Contact Stephane Bette
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number882.4300
Classification Product Code
HBG  
Date Received10/14/2016
Decision Date 01/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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