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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 / May 2026 / K254157

510(k) cleared

CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody

Medos International SARL · May 26, 2026 · K254157

FDA cleared the CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody from Medos International SARL on May 26, 2026 under K254157, 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 Dec 22, 2025. The decision came 155 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medos International SARL has 2 other decisions in the tracker over the last 12 months: K260240 (SYMPHONY Navigation Ready Instruments), K253249 (TriALTIS Spine System).

Questions & Answers

What did FDA clear under K254157?

K254157 is the FDA 510(k) for CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody, submitted by Medos International SARL. FDA's decision date was May 26, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody?

Medos International SARL, based in Le Locle, is the applicant of record for K254157.

How long did the K254157 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on May 26, 2026, 155 days later.

← All decisions in May 2026

Sources