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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 / November 2025 / K250560

510(k) cleared

BEE HA

NGMedical GmbH · Nov 21, 2025 · K250560

FDA cleared the BEE HA from NGMedical GmbH on Nov 21, 2025 under K250560, 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 Feb 25, 2025. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

NGMedical GmbH has one other decision in the tracker over the last 12 months: K261067 (BEE PLIF Cage).

Questions & Answers

What did FDA clear under K250560?

K250560 is the FDA 510(k) for BEE HA, submitted by NGMedical GmbH. FDA's decision date was Nov 21, 2025, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the BEE HA?

NGMedical GmbH, based in Nonnweiler, is the applicant of record for K250560.

How long did the K250560 review take?

FDA received the submission on Feb 25, 2025 and issued its decision on Nov 21, 2025, 269 days later.

← All decisions in November 2025

Sources