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The Tracker / February 2026 / K254148

510(k) cleared

VERTICALE GPS Instruments

Silony Medical GmbH · Feb 19, 2026 · K254148

FDA cleared the VERTICALE GPS Instruments from Silony Medical GmbH on Feb 19, 2026 under K254148, 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 59 days later, inside the 90 FDA-day goal for a 510(k).

Silony Medical GmbH has one other decision in the tracker over the last 12 months: K253921 (VERTICALE® Navigation Instruments).

Questions & Answers

What did FDA clear under K254148?

K254148 is the FDA 510(k) for VERTICALE GPS Instruments, submitted by Silony Medical GmbH. FDA's decision date was Feb 19, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the VERTICALE GPS Instruments?

Silony Medical GmbH, based in Leinfelden-Echterdingen, is the applicant of record for K254148.

How long did the K254148 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Feb 19, 2026, 59 days later.

← All decisions in February 2026

Sources