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FDA 510(k)

TraumaCad Neo (1.1)

K-Number: K243810 · 2025-06-04

ApplicantBrainlab , Ltd.
Decision Date2025-06-04
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TraumaCad Neo (1.1) is a medical device manufactured by Brainlab , Ltd.. It received FDA 510(k) clearance on 2025-06-04 under approval number K243810. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TraumaCad Neo (1.1)?

TraumaCad Neo (1.1) is a medical device that received FDA 510(k) clearance on 2025-06-04. It is manufactured by Brainlab , Ltd.. The 510(k) number is K243810.

When was TraumaCad Neo (1.1) approved by the FDA?

TraumaCad Neo (1.1) received FDA 510(k) clearance on 2025-06-04, under approval number K243810.

What company makes TraumaCad Neo (1.1)?

TraumaCad Neo (1.1) is manufactured by Brainlab , Ltd..

What is the FDA product code for TraumaCad Neo (1.1)?

The FDA product code for TraumaCad Neo (1.1) is QIH.

Other Devices by Brainlab , Ltd.

K231498TraumaCad Neo

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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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