FDA 510(k)

Aurora® Anterior Lumbar Plate Sytstem

Número K: K201079 · 2020-08-05

RequerentePrism Surgical Design Pty , Ltd.

Data da decisão2020-08-05

Código do produtoKWQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aurora® Anterior Lumbar Plate Sytstem is the device name listed in this FDA 510(k) record. The listed applicant is Prism Surgical Design Pty , Ltd.. It received FDA 510(k) clearance on 2020-08-05 under 510(k) number K201079. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aurora® Anterior Lumbar Plate Sytstem?

Aurora® Anterior Lumbar Plate Sytstem is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is Prism Surgical Design Pty , Ltd.. The 510(k) number is K201079.

When did Aurora® Anterior Lumbar Plate Sytstem receive FDA 510(k) clearance?

Aurora® Anterior Lumbar Plate Sytstem received FDA 510(k) clearance on 2020-08-05, under 510(k) number K201079.

Who is the listed applicant for Aurora® Anterior Lumbar Plate Sytstem?

The FDA 510(k) record lists Prism Surgical Design Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aurora® Anterior Lumbar Plate Sytstem?

The FDA product code for Aurora® Anterior Lumbar Plate Sytstem is KWQ.

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