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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 K162189
Device Name ANAX™ 5.5 Spinal System
Applicant
U&I Corporation
20, Sandan-Ro 76 Beon-Gil(Rd)
Uijeongbu-Si,  KR 11781
Applicant Contact Ji Yea Lee
Correspondent
U&I Corporation
20, Sandan-Ro 76 Beon-Gil(Rd)
Uijeongbu-Si,  KR 11781
Correspondent Contact Ji Yea Lee
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received08/04/2016
Decision Date 08/30/2016
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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