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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K180729
Device Name FaSet Fixation System
Applicant
Huvexel Co. , Ltd.
101-105 Megacenter, Skn Technopark,
124, Sagimakgol-Ro, Jungwon-Gu
Seongnam-Si,  KR 13207
Applicant Contact Sung Hee-Lee
Correspondent
Dio Medical Corporation
8770 W. Bryn Mawr Ave., Suite 1250
Chicago,  IL  60631
Correspondent Contact Milan George
Classification Product Code
MRW  
Date Received03/20/2018
Decision Date 06/28/2018
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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