FDA 510(k)

NCB Plating System Distal Femur and Proximal Tibia

N.º K: K192217 · 2019-09-13

Fecha de decisión2019-09-13

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

NCB Plating System Distal Femur and Proximal Tibia is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K192217. 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 NCB Plating System Distal Femur and Proximal Tibia?

NCB Plating System Distal Femur and Proximal Tibia is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Zimmer GmbH. The 510(k) number is K192217.

When did NCB Plating System Distal Femur and Proximal Tibia receive FDA 510(k) clearance?

NCB Plating System Distal Femur and Proximal Tibia received FDA 510(k) clearance on 2019-09-13, under 510(k) number K192217.

Who is the listed applicant for NCB Plating System Distal Femur and Proximal Tibia?

The FDA 510(k) record lists Zimmer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NCB Plating System Distal Femur and Proximal Tibia?

The FDA product code for NCB Plating System Distal Femur and Proximal Tibia is HRS.

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Otros registros que enlistan a Zimmer GmbH como solicitante

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Fuente oficial

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