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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 / K253444

510(k) cleared

EUROPA Posterior Cervical Fusion Navigated Instruments

MiRus, LLC · Mar 18, 2026 · K253444 · In the directory

FDA cleared the EUROPA Posterior Cervical Fusion Navigated Instruments from MiRus, LLC on Mar 18, 2026 under K253444, 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 Oct 2, 2025. The decision came 167 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

MiRus, LLC has one other decision in the tracker over the last 12 months: K252733 (ATLAS Expandable Osteotomy Wedge System).

Questions & Answers

What did FDA clear under K253444?

K253444 is the FDA 510(k) for EUROPA Posterior Cervical Fusion Navigated Instruments, submitted by MiRus, LLC. FDA's decision date was Mar 18, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the EUROPA Posterior Cervical Fusion Navigated Instruments?

MiRus, LLC, based in Marietta, GA, is the applicant of record for K253444. The company is listed in the MedDevice Startups directory.

How long did the K253444 review take?

FDA received the submission on Oct 2, 2025 and issued its decision on Mar 18, 2026, 167 days later.

← All decisions in March 2026

Sources

In the startup directory

MiRus

Cardiovascular · Marietta, GA

EUROPA Posterior Cervical Fusion Navigated Instruments

OUR COVERAGE

Questions & Answers

What did FDA clear under K253444?

Who makes the EUROPA Posterior Cervical Fusion Navigated Instruments?

How long did the K253444 review take?

EUROPA Posterior Cervical Fusion Navigated Instruments

Who makes the EUROPA Posterior Cervical Fusion Navigated Instruments?