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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 K173198
Device Name Facet Screw Fixation System
Applicant
U&i Corporation
20, Sandan-ro 76 eon-gil(Rd)
Uijeongbu-si,  KR 11781
Applicant Contact Yeon-Jung Choi
Correspondent
U&i Corporation
20, Sandan-ro 76 eon-gil(Rd)
Uijeongbu-si,  KR 11781
Correspondent Contact Yeon-Jung Choi
Classification Product Code
MRW  
Date Received10/02/2017
Decision Date 01/03/2018
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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