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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 / July 2026 / K261205

510(k) cleared

SPINEART Navigation Instrument System

Spineart SA · Jul 29, 2026 · K261205

FDA cleared the SPINEART Navigation Instrument System from Spineart SA on Jul 29, 2026 under K261205, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Apr 13, 2026. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spineart SA has 4 other decisions in the tracker over the last 12 months: K262639 (BAGUERA® C Cervical Disc Surgical Instruments), P250042 (BAGUERA®C Cervical Disc Prosthesis), K253966 (PERLA® TL Posterior Thoraco-lumbar Fixation System), K254158 (SPINEART Navigation Instrument System).

Questions & Answers

What did FDA clear under K261205?

K261205 is the FDA 510(k) for SPINEART Navigation Instrument System, submitted by Spineart SA. FDA's decision date was Jul 29, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the SPINEART Navigation Instrument System?

Spineart SA, based in Plan-Les-Ouates, is the applicant of record for K261205.

How long did the K261205 review take?

FDA received the submission on Apr 13, 2026 and issued its decision on Jul 29, 2026, 107 days later.

← All decisions in July 2026

Sources