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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 / K261209

510(k) cleared

Ion-L

SurGenTec, LLC · Jun 11, 2026 · K261209

FDA cleared the Ion-L from SurGenTec, LLC on Jun 11, 2026 under K261209, a traditional 510(k). The device falls under product code MRW, System, Facet Screw Spinal Device as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Apr 13, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

SurGenTec, LLC has 4 other decisions in the tracker over the last 12 months: K262121 (Ion-L Navigated Instruments), K260329 (Ion-C Navigation Instruments), K253604 (TiLink-L Navigation Instruments), K251714 (Ion-C).

Questions & Answers

What did FDA clear under K261209?

K261209 is the FDA 510(k) for Ion-L, submitted by SurGenTec, LLC. FDA's decision date was Jun 11, 2026, under product code MRW (System, Facet Screw Spinal Device).

Who makes the Ion-L?

SurGenTec, LLC, based in Boca Raton, FL, is the applicant of record for K261209.

How long did the K261209 review take?

FDA received the submission on Apr 13, 2026 and issued its decision on Jun 11, 2026, 59 days later.

← All decisions in June 2026

Sources