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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 / K260015

510(k) cleared

ANTERIS Thoracolumbar Plate System

SpineCraft · Mar 4, 2026 · K260015

FDA cleared the ANTERIS Thoracolumbar Plate System from SpineCraft on Mar 4, 2026 under K260015, a traditional 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 Jan 5, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

SpineCraft has one other decision in the tracker over the last 12 months: K253260 (ORIO-3D Cage System).

Questions & Answers

What did FDA clear under K260015?

K260015 is the FDA 510(k) for ANTERIS Thoracolumbar Plate System, submitted by SpineCraft. FDA's decision date was Mar 4, 2026, under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).

Who makes the ANTERIS Thoracolumbar Plate System?

SpineCraft, based in Westmont, IL, is the applicant of record for K260015.

How long did the K260015 review take?

FDA received the submission on Jan 5, 2026 and issued its decision on Mar 4, 2026, 58 days later.

← All decisions in March 2026

Sources