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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 / June 2026 / K260036

510(k) cleared

NeckTune 3D SA Cervical Cage

Medyssey Co, Ltd. · Jun 15, 2026 · K260036

FDA cleared the NeckTune 3D SA Cervical Cage from Medyssey Co, Ltd. on Jun 15, 2026 under K260036, a traditional 510(k). The device falls under product code OVE, Intervertebral Fusion Device With Integrated Fixation, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 6, 2026. The decision came 160 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Medyssey Co, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260036?

K260036 is the FDA 510(k) for NeckTune 3D SA Cervical Cage, submitted by Medyssey Co, Ltd.. FDA's decision date was Jun 15, 2026, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the NeckTune 3D SA Cervical Cage?

Medyssey Co, Ltd., based in Jecheon-Si, is the applicant of record for K260036.

How long did the K260036 review take?

FDA received the submission on Jan 6, 2026 and issued its decision on Jun 15, 2026, 160 days later.

← All decisions in June 2026