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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 K262489
Device Name BluEX Cervical Expandable Cage System
Applicant
L&K BIOMED Co., Ltd.
#101, 201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil
Giheung-Gu,
Yongin-Si,  KR 17015
Applicant Contact Kihyang Kim
Correspondent
L&K BIOMED Co., Ltd.
#101, 201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil
Giheung-Gu,
Yongin-Si,  KR 17015
Correspondent Contact Kihyang Kim
Regulation Number888.3080
Classification Product Code
ODP  
Date Received07/20/2026
Decision Date 08/18/2026
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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