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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
Original Applicant
L&K BIOMED CO., LTD
#1104, ace high-end tower 3
cha, 371-50 gasan-dong
geumcheon-gu, seoul,  KR 153-803
Original 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
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