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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K173524
Device Name ANAX 5.5™ Spinal System
Applicant
U&I Corporation
20, Sandan-Ro 76 Beon-Gil(Rd)
Uijeongbu-Si,  KR 11781
Applicant Contact Jee Ae Bang
Correspondent
U&I Corporation
20, Sandan-Ro 76 Beon-Gil(Rd)
Uijeongbu-Si,  KR 11781
Correspondent Contact Jee Ae Bang
Regulation Number888.3070
Classification Product Code
NKB  
Date Received11/14/2017
Decision Date 12/13/2017
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
Recalls CDRH Recalls
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