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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
ROOM 1104, ACE HIGH-END TOWER3
371-50 GASAN-DONG, GEUMCHEON-G
HEE KYEONG JOO,  KR 153803
Applicant Contact HEE KYEONG JOO
Correspondent
L & K BIOMED CO., LTD
ROOM 1104, ACE HIGH-END TOWER3
371-50 GASAN-DONG, GEUMCHEON-G
HEE KYEONG JOO,  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
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