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The Tracker / September 2026 / K261861

510(k) cleared

SPINEsim v1.0

Mdsim S.A. · Sep 15, 2026 · K261861

FDA cleared the SPINEsim v1.0 from Mdsim S.A. on Sep 15, 2026 under K261861, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 4, 2026. The decision came 103 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Mdsim S.A. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261861?

K261861 is the FDA 510(k) for SPINEsim v1.0, submitted by Mdsim S.A.. FDA's decision date was Sep 15, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the SPINEsim v1.0?

Mdsim S.A., based in Esch-Sur-Alzette, is the applicant of record for K261861.

How long did the K261861 review take?

FDA received the submission on Jun 4, 2026 and issued its decision on Sep 15, 2026, 103 days later.

← All decisions in September 2026