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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 K042928
Device Name MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
Applicant
U&I Corp.
529-1 Yonghyun-Dong
Uijungbu, Gyeonggi-Do,  KR 480-050
Applicant Contact BETTY LIM
Correspondent
U&I Corp.
529-1 Yonghyun-Dong
Uijungbu, Gyeonggi-Do,  KR 480-050
Correspondent Contact BETTY LIM
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received10/22/2004
Decision Date 02/17/2005
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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