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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 / June 2026 / K261279

510(k) cleared

DeltaNEC Interbody System

Nexus Spine · Jun 22, 2026 · K261279

FDA cleared the DeltaNEC Interbody System from Nexus Spine on Jun 22, 2026 under K261279, a traditional 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 Apr 17, 2026. The decision came 66 days later, inside the 90 FDA-day goal for a 510(k).

Nexus Spine has one other decision in the tracker over the last 12 months: K253331 (PressON Spinal Fixation System).

Questions & Answers

What did FDA clear under K261279?

K261279 is the FDA 510(k) for DeltaNEC Interbody System, submitted by Nexus Spine. FDA's decision date was Jun 22, 2026, under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).

Who makes the DeltaNEC Interbody System?

Nexus Spine, based in Salt Lake City, UT, is the applicant of record for K261279.

How long did the K261279 review take?

FDA received the submission on Apr 17, 2026 and issued its decision on Jun 22, 2026, 66 days later.

← All decisions in June 2026

Sources