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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 K173201
Device Name UNITY Sacroiliac Joint Fixation System
Applicant
Huvexel Co. , Ltd.
101-105 Megacenter, Sk Technopark, 124,
Sagimakgol-Ro Jungwon-Gu
Seongnam-Si,  KR 124
Applicant Contact Sung Hee-Lee
Correspondent
RQMIS, Inc.
110 Haverhill Rd., Suite 526
Amesbury,  MA  01913
Correspondent Contact Michael A. Patz
Regulation Number888.3040
Classification Product Code
OUR  
Date Received10/02/2017
Decision Date 04/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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