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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
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