WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K253195

510(k) cleared

TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems

ZheJiang Decans Medical Devices Co., Ltd. · Jun 2, 2026 · K253195

FDA cleared the TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems from ZheJiang Decans Medical Devices Co., Ltd. on Jun 2, 2026 under K253195, a traditional 510(k). The device falls under product code NKG, Posterior Cervical Screw System, regulated at 21 CFR 888.3075 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 26, 2025. The decision came 249 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), K252930 (AQUA Laminoplasty Systems), K253130 (Dione PEEK Screw System), K252776 (ARIES Anterior Cervical Plate Systems).

Questions & Answers

What did FDA clear under K253195?

K253195 is the FDA 510(k) for TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems, submitted by ZheJiang Decans Medical Devices Co., Ltd.. FDA's decision date was Jun 2, 2026, under product code NKG (Posterior Cervical Screw System).

Who makes the TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems?

ZheJiang Decans Medical Devices Co., Ltd., based in Jiaxing, is the applicant of record for K253195.

How long did the K253195 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jun 2, 2026, 249 days later.

← All decisions in June 2026