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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
Applicant
L & K BIOMED CO., LTD
ROOM 1104, ACE HIGH-END TOWER3
371-50 GASAN-DONG, GEUMCHEON-G
SEOUL,  KR 153803
Applicant Contact KI HYANG KIM
Correspondent
L & K BIOMED CO., LTD
ROOM 1104, ACE HIGH-END TOWER3
371-50 GASAN-DONG, GEUMCHEON-G
SEOUL,  KR 153803
Correspondent Contact KI HYANG KIM
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received03/23/2012
Decision Date 05/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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