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FDA 510(k)

MirrorMe3D Modeling System

K-Number: K212981 · 2022-04-22

ApplicantMirrorme3D, LLC
Decision Date2022-04-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MirrorMe3D Modeling System is a medical device manufactured by Mirrorme3D, LLC. It received FDA 510(k) clearance on 2022-04-22 under approval number K212981. 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 MirrorMe3D Modeling System?

MirrorMe3D Modeling System is a medical device that received FDA 510(k) clearance on 2022-04-22. It is manufactured by Mirrorme3D, LLC. The 510(k) number is K212981.

When was MirrorMe3D Modeling System approved by the FDA?

MirrorMe3D Modeling System received FDA 510(k) clearance on 2022-04-22, under approval number K212981.

What company makes MirrorMe3D Modeling System?

MirrorMe3D Modeling System is manufactured by Mirrorme3D, LLC.

What is the FDA product code for MirrorMe3D Modeling System?

The FDA product code for MirrorMe3D Modeling System is LLZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026)

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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.

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