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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 K110783
Device Name VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
Applicant
L&K BIOMED Co., Ltd.
Rm. 1104, Ace High-End Tower3
371-50 Gasan-Dong, Geumcheon-G
Seoul,  KR 153803
Applicant Contact HEE KYEONG JOO
Correspondent
L&K BIOMED Co., Ltd.
Rm. 1104, Ace High-End Tower3
371-50 Gasan-Dong, Geumcheon-G
Seoul,  KR 153803
Correspondent Contact HEE KYEONG JOO
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/21/2011
Decision Date 10/24/2011
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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