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FDA 510(k)

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface

K-Number: K240431 · 2024-07-24

ApplicantBrainlab AG
Decision Date2024-07-24
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K240431. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface?

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Brainlab AG. The 510(k) number is K240431.

When did ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface receive FDA 510(k) clearance?

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface received FDA 510(k) clearance on 2024-07-24, under 510(k) number K240431.

Who is the listed applicant for ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface?

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

What is the FDA product code for ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface?

The FDA product code for ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface is IYE.

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Related Devices (Code: IYE)

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.

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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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