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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 / May 2026 / K253676

510(k) cleared

CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)

Providence Medical Technology, Inc. · May 14, 2026 · K253676

FDA cleared the CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D) from Providence Medical Technology, Inc. on May 14, 2026 under K253676, 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 Nov 21, 2025. The decision came 174 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Providence Medical Technology, Inc. has 2 other decisions in the tracker over the last 12 months: K261665 (CORUS Navigation System-GN), K253190 (CORUS-LX Implant).

Questions & Answers

What did FDA clear under K253676?

K253676 is the FDA 510(k) for CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D), submitted by Providence Medical Technology, Inc.. FDA's decision date was May 14, 2026, under product code MRW (System, Facet Screw Spinal Device).

Who makes the CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)?

Providence Medical Technology, Inc., based in Pleasanton, CA, is the applicant of record for K253676.

How long did the K253676 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on May 14, 2026, 174 days later.

← All decisions in May 2026

Sources