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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K173131
Device Name Rexious Spinal Fixation System
Applicant
Huvexel Co., Ltd
101-105 Megacenter, SK Technopark, 124,
Sagimakgol-ro Jungwon-gu
Seongnam-si,  KR 13207
Applicant Contact Sung Hee-Lee
Correspondent
Dio Medical Corporation
8770 W Bryn Mawr Ave, Ste 1250
Chicago,  IL  60631
Correspondent Contact Milan George
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/29/2017
Decision Date 12/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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