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FDA 510(k)

MagnetOs Flex Matrix

K-Number: K213959 · 2022-04-14

ApplicantKuros Biosciences B.V
Decision Date2022-04-14
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MagnetOs Flex Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Kuros Biosciences B.V. It received FDA 510(k) clearance on 2022-04-14 under 510(k) number K213959. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MagnetOs Flex Matrix?

MagnetOs Flex Matrix is a medical device that received FDA 510(k) clearance on 2022-04-14. The listed applicant is Kuros Biosciences B.V. The 510(k) number is K213959.

When did MagnetOs Flex Matrix receive FDA 510(k) clearance?

MagnetOs Flex Matrix received FDA 510(k) clearance on 2022-04-14, under 510(k) number K213959.

Who is the listed applicant for MagnetOs Flex Matrix?

The FDA 510(k) record lists Kuros Biosciences B.V as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagnetOs Flex Matrix?

The FDA product code for MagnetOs Flex Matrix is MQV.

Related Clinical Trials

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.

NCT05037968MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral FusionRECRUITING

Other records listing Kuros Biosciences B.V 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.

K243474MagnetOs MISK240442MagnetOs PuttyK232347MagnetOs GranulesK230736MagnetOs PuttyK233607MagnetOs Easypack PuttyK233245MagnetOs Flex Matrix

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Related Devices (Code: MQV)

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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