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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 K151677
Device Name LnK Cervical Interbody Fusion Cage System
Applicant
L & K Biomed Co., Ltd.
#201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil
Giheung-Gu, Yongin-Si,  KR 446-916
Applicant Contact Yerim An
Correspondent
L & K Biomed Co., Ltd.
#201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil
Giheung-Gu, Yongin-Si,  KR 446-916
Correspondent Contact Yerim An
Regulation Number888.3080
Classification Product Code
ODP  
Date Received06/22/2015
Decision Date 07/15/2015
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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