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FDA 510(k)

Quadsense (Quadsense and Quadsense Pro)

K-Number: K252524 · 2025-09-09

ApplicantEventum Orthopaedics, Ltd.
Decision Date2025-09-09
Product CodeONN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Quadsense (Quadsense and Quadsense Pro) is a medical device manufactured by Eventum Orthopaedics, Ltd.. It received FDA 510(k) clearance on 2025-09-09 under approval number K252524. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quadsense (Quadsense and Quadsense Pro)?

Quadsense (Quadsense and Quadsense Pro) is a medical device that received FDA 510(k) clearance on 2025-09-09. It is manufactured by Eventum Orthopaedics, Ltd.. The 510(k) number is K252524.

When was Quadsense (Quadsense and Quadsense Pro) approved by the FDA?

Quadsense (Quadsense and Quadsense Pro) received FDA 510(k) clearance on 2025-09-09, under approval number K252524.

What company makes Quadsense (Quadsense and Quadsense Pro)?

Quadsense (Quadsense and Quadsense Pro) is manufactured by Eventum Orthopaedics, Ltd..

What is the FDA product code for Quadsense (Quadsense and Quadsense Pro)?

The FDA product code for Quadsense (Quadsense and Quadsense Pro) is ONN.

Other Devices by Eventum Orthopaedics, Ltd.

K241298QUADSENSE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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