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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 / K253190

510(k) cleared

CORUS-LX Implant

Providence Medical Technology, Inc. · Nov 20, 2025 · K253190

FDA cleared the CORUS-LX Implant from Providence Medical Technology, Inc. on Nov 20, 2025 under K253190, a traditional 510(k). The device falls under product code MRW, System, Facet Screw Spinal Device as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Sep 26, 2025. The decision came 55 days later, inside the 90 FDA-day goal for a 510(k).

Providence Medical Technology, Inc. has 2 other decisions in the tracker over the last 12 months: K261665 (CORUS Navigation System-GN), K253676 (CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)).

Questions & Answers

What did FDA clear under K253190?

K253190 is the FDA 510(k) for CORUS-LX Implant, submitted by Providence Medical Technology, Inc.. FDA's decision date was Nov 20, 2025, under product code MRW (System, Facet Screw Spinal Device).

Who makes the CORUS-LX Implant?

Providence Medical Technology, Inc., based in Pleasanton, CA, is the applicant of record for K253190.

How long did the K253190 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Nov 20, 2025, 55 days later.

← All decisions in November 2025

Sources