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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 / March 2026 / K253432

510(k) cleared

DiversiVy Facet Screw System

Vy Spine, LLC · Mar 19, 2026 · K253432

FDA cleared the DiversiVy Facet Screw System from Vy Spine, LLC on Mar 19, 2026 under K253432, 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 Oct 1, 2025. The decision came 169 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Vy Spine, LLC has 2 other decisions in the tracker over the last 12 months: K260697 (VyPlate Anterior Cervical Plate System), K253158 (VyBrate VBR System).

Questions & Answers

What did FDA clear under K253432?

K253432 is the FDA 510(k) for DiversiVy Facet Screw System, submitted by Vy Spine, LLC. FDA's decision date was Mar 19, 2026, under product code MRW (System, Facet Screw Spinal Device).

Who makes the DiversiVy Facet Screw System?

Vy Spine, LLC, based in Bountiful, UT, is the applicant of record for K253432.

How long did the K253432 review take?

FDA received the submission on Oct 1, 2025 and issued its decision on Mar 19, 2026, 169 days later.

← All decisions in March 2026

Sources