FDA 510(k)

Medline UNITE® MIS Foot Recon Screw System

Número K: K241359 · 2024-08-02

Data da decisão2024-08-02

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medline UNITE® MIS Foot Recon Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241359. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medline UNITE® MIS Foot Recon Screw System?

Medline UNITE® MIS Foot Recon Screw System is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Medline Industries, LP. The 510(k) number is K241359.

When did Medline UNITE® MIS Foot Recon Screw System receive FDA 510(k) clearance?

Medline UNITE® MIS Foot Recon Screw System received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241359.

Who is the listed applicant for Medline UNITE® MIS Foot Recon Screw System?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline UNITE® MIS Foot Recon Screw System?

The FDA product code for Medline UNITE® MIS Foot Recon Screw System is HWC. This falls under the Cardiovascular category.

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Fonte oficial

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