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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K120879
Device Name LEXUS CERVICAL FIXATION SYSTEM
Original Applicant
L & K BIOMED CO., LTD
room 1104, ace high-end tower3
371-50 gasan-dong, geumcheon-g
seoul,  KS 153803
Original Contact ki hyang kim
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received03/26/2012
Decision Date 05/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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