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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 / March 2026 / K260697

510(k) cleared

VyPlate Anterior Cervical Plate System

Vy Spine, LLC · Mar 27, 2026 · K260697

FDA cleared the VyPlate Anterior Cervical Plate System from Vy Spine, LLC on Mar 27, 2026 under K260697, a special 510(k). The device falls under product code KWQ, Appliance, Fixation, Spinal Intervertebral Body, regulated at 21 CFR 888.3060 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 4, 2026. The decision came 23 days later, inside the 90 FDA-day goal for a 510(k).

Vy Spine, LLC has 2 other decisions in the tracker over the last 12 months: K253432 (DiversiVy Facet Screw System), K253158 (VyBrate VBR System).

Questions & Answers

What did FDA clear under K260697?

K260697 is the FDA 510(k) for VyPlate Anterior Cervical Plate System, submitted by Vy Spine, LLC. FDA's decision date was Mar 27, 2026, under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).

Who makes the VyPlate Anterior Cervical Plate System?

Vy Spine, LLC, based in Bountiful, UT, is the applicant of record for K260697.

How long did the K260697 review take?

FDA received the submission on Mar 4, 2026 and issued its decision on Mar 27, 2026, 23 days later.

← All decisions in March 2026

Sources