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The Tracker / August 2026 / K262489

510(k) cleared

BluEX Cervical Expandable Cage System

L&K BIOMED Co., Ltd. · Aug 18, 2026 · K262489

FDA cleared the BluEX Cervical Expandable Cage System from L&K BIOMED Co., Ltd. on Aug 18, 2026 under K262489, a special 510(k). The device falls under product code ODP, Intervertebral Fusion Device With Bone Graft, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 20, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

L&K BIOMED Co., Ltd. has 5 other decisions in the tracker over the last 12 months: K260840 (BluEX Cervical Expandable Cage System), K261112 (CastleLoc-P Anterior Cervical Plate System), K261130 (AccelFix Spinal Fixation System), K260448 (CastleLoc Pectus Bar System).

Questions & Answers

What did FDA clear under K262489?

K262489 is the FDA 510(k) for BluEX Cervical Expandable Cage System, submitted by L&K BIOMED Co., Ltd.. FDA's decision date was Aug 18, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the BluEX Cervical Expandable Cage System?

L&K BIOMED Co., Ltd., based in Yongin-Si, is the applicant of record for K262489.

How long did the K262489 review take?

FDA received the submission on Jul 20, 2026 and issued its decision on Aug 18, 2026, 29 days later.

← All decisions in August 2026

Sources