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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 / February 2026 / K260038

510(k) cleared

E3D-C Interbody System

Evolution Spine · Feb 4, 2026 · K260038

FDA cleared the E3D-C Interbody System from Evolution Spine on Feb 4, 2026 under K260038, a special 510(k). The device falls under product code OVE, Intervertebral Fusion Device With Integrated Fixation, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 6, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Evolution Spine has one other decision in the tracker over the last 12 months: K262094 (E3D-C Interbody System).

Questions & Answers

What did FDA clear under K260038?

K260038 is the FDA 510(k) for E3D-C Interbody System, submitted by Evolution Spine. FDA's decision date was Feb 4, 2026, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the E3D-C Interbody System?

Evolution Spine, based in Dallas, TX, is the applicant of record for K260038.

How long did the K260038 review take?

FDA received the submission on Jan 6, 2026 and issued its decision on Feb 4, 2026, 29 days later.

← All decisions in February 2026

Sources