FDA 510(k)

KeYi Total Hip System

N.º K: K191826 · 2020-05-14

SolicitanteBeijing Keyi Medical Device Technology Co., Ltd.

Fecha de decisión2020-05-14

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

KeYi Total Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K191826. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the KeYi Total Hip System?

KeYi Total Hip System is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. The 510(k) number is K191826.

When did KeYi Total Hip System receive FDA 510(k) clearance?

KeYi Total Hip System received FDA 510(k) clearance on 2020-05-14, under 510(k) number K191826.

Who is the listed applicant for KeYi Total Hip System?

The FDA 510(k) record lists Beijing Keyi Medical Device Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KeYi Total Hip System?

The FDA product code for KeYi Total Hip System is LPH.

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Otros registros que enlistan a Beijing Keyi Medical Device Technology Co., Ltd. como solicitante

K230120KeYi Total Knee System K190567KeYi Spinal Fixation System K162380Locking Plate System

Dispositivos relacionados (Código: LPH)

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Fuente oficial

Ver en la base de datos de la FDA →

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