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FDA 510(k)

Stereotaxic Guiding Surgical Devices, NaoTrac S

K-Number: K242575 · 2025-05-23

ApplicantBrain Navi Biotechnology Co., Ltd.
Decision Date2025-05-23
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stereotaxic Guiding Surgical Devices, NaoTrac S is a medical device manufactured by Brain Navi Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-23 under approval number K242575. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stereotaxic Guiding Surgical Devices, NaoTrac S?

Stereotaxic Guiding Surgical Devices, NaoTrac S is a medical device that received FDA 510(k) clearance on 2025-05-23. It is manufactured by Brain Navi Biotechnology Co., Ltd.. The 510(k) number is K242575.

When was Stereotaxic Guiding Surgical Devices, NaoTrac S approved by the FDA?

Stereotaxic Guiding Surgical Devices, NaoTrac S received FDA 510(k) clearance on 2025-05-23, under approval number K242575.

What company makes Stereotaxic Guiding Surgical Devices, NaoTrac S?

Stereotaxic Guiding Surgical Devices, NaoTrac S is manufactured by Brain Navi Biotechnology Co., Ltd..

What is the FDA product code for Stereotaxic Guiding Surgical Devices, NaoTrac S?

The FDA product code for Stereotaxic Guiding Surgical Devices, NaoTrac S is HAW.

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Related PubMed Literature

PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41886403 Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990 to 2023. Urology practice (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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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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