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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, Lumbar
510(k) Number K121096
Device Name VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE 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 Number888.3080
Classification Product Code
MAX  
Date Received04/11/2012
Decision Date 07/06/2012
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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