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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K113509
Device Name LEXUS ANTERIOR CERVICAL PLATE SYSTEM
Applicant
L & K Biomed Co., Ltd.
#1104, Ace High-End Tower 3
Cha, 371-50 Gasan-Dong
Geumcheon-Gu, Seoul,  KR 153-803
Applicant Contact HEE KYEONG JOO
Correspondent
L & K Biomed Co., Ltd.
#1104, Ace High-End Tower 3
Cha, 371-50 Gasan-Dong
Geumcheon-Gu, Seoul,  KR 153-803
Correspondent Contact HEE KYEONG JOO
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/28/2011
Decision Date 01/20/2012
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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