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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 / April 2026 / K261067

510(k) cleared

BEE PLIF Cage

NGMedical GmbH · Apr 30, 2026 · K261067

FDA cleared the BEE PLIF Cage from NGMedical GmbH on Apr 30, 2026 under K261067, a special 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 1, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

NGMedical GmbH has one other decision in the tracker over the last 12 months: K250560 (BEE HA).

Questions & Answers

What did FDA clear under K261067?

K261067 is the FDA 510(k) for BEE PLIF Cage, submitted by NGMedical GmbH. FDA's decision date was Apr 30, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the BEE PLIF Cage?

NGMedical GmbH, based in Nonnweiler, is the applicant of record for K261067.

How long did the K261067 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Apr 30, 2026, 29 days later.

← All decisions in April 2026

Sources