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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 a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2024-07-24 under approval 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. It is manufactured by Brainlab AG. The 510(k) number is K240431.

When was ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface approved by the FDA?

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

What company makes ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface?

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface is manufactured by Brainlab AG.

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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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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