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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
Applicant
L & K Biomed Co., Ltd.
#1104, Ace High-End Tower 3
Cha, 371-50 Gasan-Dong
Geumcheon-Gu, Seoul,  KR 153-803
Applicant Contact KI HYANG KIM
Correspondent
L & K Biomed Co., Ltd.
#1104, Ace High-End Tower 3
Cha, 371-50 Gasan-Dong
Geumcheon-Gu, Seoul,  KR 153-803
Correspondent Contact KI HYANG KIM
Regulation Number888.3080
Classification Product Code
ODP  
Date Received03/20/2012
Decision Date 05/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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