FDA 510(k)

SPINEsim v1.0

K-Number: K261861 · 2026-09-15

Decision Date2026-09-15

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SPINEsim v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Mdsim S.A.. It received FDA 510(k) clearance on 2026-09-15 under 510(k) number K261861. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINEsim v1.0?

SPINEsim v1.0 is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Mdsim S.A.. The 510(k) number is K261861.

When did SPINEsim v1.0 receive FDA 510(k) clearance?

SPINEsim v1.0 received FDA 510(k) clearance on 2026-09-15, under 510(k) number K261861.

Who is the listed applicant for SPINEsim v1.0?

The FDA 510(k) record lists Mdsim S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINEsim v1.0?

The FDA product code for SPINEsim v1.0 is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC K261500KBA3D (v2.4.0)S.M.A.I.O K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.