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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with bone graft, cervical
510(k) Number K120840
Device Name LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
Original Applicant
L&K BIOMED CO., LTD
#1104, ace high-end tower 3
cha, 371-50 gasan-dong
geumcheon-gu, seoul,  KS 153-803
Original Contact ki hyang kim
Regulation Number888.3080
Classification Product Code
ODP  
Date Received03/21/2012
Decision Date 05/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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