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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K100706
Device Name VENUS BASIC SPINAL 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 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 Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received03/12/2010
Decision Date 07/22/2010
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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