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FDA 510(k)

Mendaera Guidance System

K-Number: K250524 · 2025-07-02

ApplicantMendaera, Inc.
Decision Date2025-07-02
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mendaera Guidance System is a medical device manufactured by Mendaera, Inc.. It received FDA 510(k) clearance on 2025-07-02 under approval number K250524. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mendaera Guidance System?

Mendaera Guidance System is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by Mendaera, Inc.. The 510(k) number is K250524.

When was Mendaera Guidance System approved by the FDA?

Mendaera Guidance System received FDA 510(k) clearance on 2025-07-02, under approval number K250524.

What company makes Mendaera Guidance System?

Mendaera Guidance System is manufactured by Mendaera, Inc..

What is the FDA product code for Mendaera Guidance System?

The FDA product code for Mendaera Guidance System is ITX.

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Related PubMed Literature

PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37306642 Regulatory Framework for Implantable Neurostimulation Devices: Comparison of Systems in the US and European Union. Neuromodulation : journal of the International Neuromodulation Society (2024) PMID: 29659675 Facing the Inevitable: Being Prepared for Regulatory Requirements for Laboratory Developed Tests. American journal of clinical pathology (2018)

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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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