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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K260840

510(k) cleared

BluEX Cervical Expandable Cage System

L&K BIOMED Co., Ltd. · May 16, 2026 · K260840

FDA cleared the BluEX Cervical Expandable Cage System from L&K BIOMED Co., Ltd. on May 16, 2026 under K260840, a traditional 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 Mar 16, 2026. The decision came 61 days later, inside the 90 FDA-day goal for a 510(k).

L&K BIOMED Co., Ltd. has 4 other decisions in the tracker over the last 12 months: K261112 (CastleLoc-P Anterior Cervical Plate System), K261130 (AccelFix Spinal Fixation System), K260448 (CastleLoc Pectus Bar System), K251940 (PathLoc Lumbar Plate System).

Questions & Answers

What did FDA clear under K260840?

K260840 is the FDA 510(k) for BluEX Cervical Expandable Cage System, submitted by L&K BIOMED Co., Ltd.. FDA's decision date was May 16, 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 K260840.

How long did the K260840 review take?

FDA received the submission on Mar 16, 2026 and issued its decision on May 16, 2026, 61 days later.

← All decisions in May 2026

Sources