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FDA 510(k)

Lever Action Plate System

N.º K: K200834 · 2020-06-25

SolicitanteMcginley Orthpaedic Innovations, LLC
Fecha de decisión2020-06-25
Código de productoHRS
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Lever Action Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Mcginley Orthpaedic Innovations, LLC. It received FDA 510(k) clearance on 2020-06-25 under 510(k) number K200834. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Lever Action Plate System?

Lever Action Plate System is a medical device that received FDA 510(k) clearance on 2020-06-25. The listed applicant is Mcginley Orthpaedic Innovations, LLC. The 510(k) number is K200834.

When did Lever Action Plate System receive FDA 510(k) clearance?

Lever Action Plate System received FDA 510(k) clearance on 2020-06-25, under 510(k) number K200834.

Who is the listed applicant for Lever Action Plate System?

The FDA 510(k) record lists Mcginley Orthpaedic Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lever Action Plate System?

The FDA product code for Lever Action Plate System is HRS.

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Dispositivos relacionados (Código: HRS)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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