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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 / March 2026 / K260240

510(k) cleared

SYMPHONY Navigation Ready Instruments

Medos International SARL · Mar 27, 2026 · K260240

FDA cleared the SYMPHONY Navigation Ready Instruments from Medos International SARL on Mar 27, 2026 under K260240, 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 Jan 26, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Medos International SARL has 2 other decisions in the tracker over the last 12 months: K254157 (CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody), K253249 (TriALTIS Spine System).

Questions & Answers

What did FDA clear under K260240?

K260240 is the FDA 510(k) for SYMPHONY Navigation Ready Instruments, submitted by Medos International SARL. FDA's decision date was Mar 27, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the SYMPHONY Navigation Ready Instruments?

Medos International SARL, based in Le Locle, is the applicant of record for K260240.

How long did the K260240 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Mar 27, 2026, 60 days later.

← All decisions in March 2026

Sources