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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 K083077
Device Name ULC SPINAL PEDICLE SCREW SYSTEM
Applicant
Otis Biotech Co., Ltd.
514, 2-Ba Block, Jungwang-Dong
Sihma Industrial Complex
Siheung-Si, Gyounggi-Do,  KR 429-450
Applicant Contact JISUK YOO
Correspondent
Otis Biotech Co., Ltd.
514, 2-Ba Block, Jungwang-Dong
Sihma Industrial Complex
Siheung-Si, Gyounggi-Do,  KR 429-450
Correspondent Contact JISUK YOO
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received10/16/2008
Decision Date 10/26/2009
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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