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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 / January 2026 / K251714

510(k) cleared

Ion-C

SurGenTec, LLC · Jan 16, 2026 · K251714

FDA cleared the Ion-C from SurGenTec, LLC on Jan 16, 2026 under K251714, 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 Jun 3, 2025. The decision came 227 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

SurGenTec, LLC has 4 other decisions in the tracker over the last 12 months: K262121 (Ion-L Navigated Instruments), K261209 (Ion-L), K260329 (Ion-C Navigation Instruments), K253604 (TiLink-L Navigation Instruments).

Questions & Answers

What did FDA clear under K251714?

K251714 is the FDA 510(k) for Ion-C, submitted by SurGenTec, LLC. FDA's decision date was Jan 16, 2026, under product code MRW (System, Facet Screw Spinal Device).

Who makes the Ion-C?

SurGenTec, LLC, based in Boca Raton, FL, is the applicant of record for K251714.

How long did the K251714 review take?

FDA received the submission on Jun 3, 2025 and issued its decision on Jan 16, 2026, 227 days later.

← All decisions in January 2026

Sources