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FDA 510(k)

QUADSENSE

K-Number: K241298 · 2024-10-04

ApplicantEventum Orthopaedics, Ltd.
Decision Date2024-10-04
Product CodeONN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

QUADSENSE is the device name listed in this FDA 510(k) record. The listed applicant is Eventum Orthopaedics, Ltd.. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K241298. 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 is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Eventum Orthopaedics, Ltd.. The 510(k) number is K241298.

When did QUADSENSE receive FDA 510(k) clearance?

QUADSENSE received FDA 510(k) clearance on 2024-10-04, under 510(k) number K241298.

Who is the listed applicant for QUADSENSE?

The FDA 510(k) record lists Eventum Orthopaedics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUADSENSE?

The FDA product code for QUADSENSE is ONN.

Other records listing Eventum Orthopaedics, Ltd. as applicant

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.

K252524Quadsense (Quadsense and Quadsense Pro)

Related Devices (Code: ONN)

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

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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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