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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.
Rm. 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.
Rm. 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
Predetermined Change
Control Plan Authorized		 No
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