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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 / K253921

510(k) cleared

VERTICALE® Navigation Instruments

Silony Medical GmbH · Jun 26, 2026 · K253921

FDA cleared the VERTICALE® Navigation Instruments from Silony Medical GmbH on Jun 26, 2026 under K253921, 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 8, 2025. The decision came 200 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Silony Medical GmbH has one other decision in the tracker over the last 12 months: K254148 (VERTICALE GPS Instruments).

Questions & Answers

What did FDA clear under K253921?

K253921 is the FDA 510(k) for VERTICALE® Navigation Instruments, submitted by Silony Medical GmbH. FDA's decision date was Jun 26, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the VERTICALE® Navigation Instruments?

Silony Medical GmbH, based in Leinfelden-Echterdingen, is the applicant of record for K253921.

How long did the K253921 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on Jun 26, 2026, 200 days later.

← All decisions in June 2026

Sources