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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 / K252542

510(k) cleared

LEO Spinal System

ZheJiang Decans Medical Devices Co., Ltd. · Apr 29, 2026 · K252542

FDA cleared the LEO Spinal System from ZheJiang Decans Medical Devices Co., Ltd. on Apr 29, 2026 under K252542, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 12, 2025. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ZheJiang Decans Medical Devices Co., Ltd. has 7 other decisions in the tracker over the last 12 months: K253046 (HERA Interlocking Intramedullary Nailing System), K253195 (TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems), K252930 (AQUA Laminoplasty Systems), K253130 (Dione PEEK Screw System).

Questions & Answers

What did FDA clear under K252542?

K252542 is the FDA 510(k) for LEO Spinal System, submitted by ZheJiang Decans Medical Devices Co., Ltd.. FDA's decision date was Apr 29, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the LEO Spinal System?

ZheJiang Decans Medical Devices Co., Ltd., based in Jiaxing City, is the applicant of record for K252542.

How long did the K252542 review take?

FDA received the submission on Aug 12, 2025 and issued its decision on Apr 29, 2026, 260 days later.

← All decisions in April 2026