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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 / July 2026 / K262094

510(k) cleared

E3D-C Interbody System

Evolution Spine · Jul 22, 2026 · K262094

FDA cleared the E3D-C Interbody System from Evolution Spine on Jul 22, 2026 under K262094, 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 Jun 22, 2026. The decision came 30 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: K260038 (E3D-C Interbody System).

Questions & Answers

What did FDA clear under K262094?

K262094 is the FDA 510(k) for E3D-C Interbody System, submitted by Evolution Spine. FDA's decision date was Jul 22, 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 K262094.

How long did the K262094 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Jul 22, 2026, 30 days later.

← All decisions in July 2026

Sources