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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 / K261351

510(k) cleared

SALGINA 2.5mm Distal Radius System

Bonebridge AG · Jun 26, 2026 · K261351

FDA cleared the SALGINA 2.5mm Distal Radius System from Bonebridge AG on Jun 26, 2026 under K261351, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 24, 2026. The decision came 63 days later, inside the 90 FDA-day goal for a 510(k).

Bonebridge AG has 2 other decisions in the tracker over the last 12 months: K260228 (POYA 3.5mm Medial Proximal Tibia System), K252191 (BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System).

Questions & Answers

What did FDA clear under K261351?

K261351 is the FDA 510(k) for SALGINA 2.5mm Distal Radius System, submitted by Bonebridge AG. FDA's decision date was Jun 26, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the SALGINA 2.5mm Distal Radius System?

Bonebridge AG, based in Zug, is the applicant of record for K261351.

How long did the K261351 review take?

FDA received the submission on Apr 24, 2026 and issued its decision on Jun 26, 2026, 63 days later.

← All decisions in June 2026

Sources