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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K143417
Device Name ANAX 5.5 Spinal System
Applicant
U&I Corporation
20, Sandan-Ro 76beon-Gil (Rd.)
Uijeongbu-Si,  KR 480-859
Applicant Contact Young-Geun Kim
Correspondent
U&I Corporation
20, Sandan-Ro 76beon-Gil(Rd)
Uijeongbu-Si, Gyeonggi-Do,  KR 480-859
Correspondent Contact Young-Geun Kim
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received11/28/2014
Decision Date 02/25/2015
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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