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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 / February 2026 / K254017

510(k) cleared

SWINGO-3D Lumbar Cage System

Implanet · Feb 26, 2026 · K254017

FDA cleared the SWINGO-3D Lumbar Cage System from Implanet on Feb 26, 2026 under K254017, a traditional 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 15, 2025. The decision came 73 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Implanet in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254017?

K254017 is the FDA 510(k) for SWINGO-3D Lumbar Cage System, submitted by Implanet. FDA's decision date was Feb 26, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the SWINGO-3D Lumbar Cage System?

Implanet, based in Allee Francois Magendie, is the applicant of record for K254017.

How long did the K254017 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Feb 26, 2026, 73 days later.

← All decisions in February 2026