FDA 510(k)

Australis Anterior Lumbar Cage System

Número K: K202820 · 2020-12-22

RequerentePrism Surgical Designs Pty, Ltd.

Data da decisão2020-12-22

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Australis Anterior Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Prism Surgical Designs Pty, Ltd.. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K202820. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Australis Anterior Lumbar Cage System?

Australis Anterior Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Prism Surgical Designs Pty, Ltd.. The 510(k) number is K202820.

When did Australis Anterior Lumbar Cage System receive FDA 510(k) clearance?

Australis Anterior Lumbar Cage System received FDA 510(k) clearance on 2020-12-22, under 510(k) number K202820.

Who is the listed applicant for Australis Anterior Lumbar Cage System?

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

What is the FDA product code for Australis Anterior Lumbar Cage System?

The FDA product code for Australis Anterior Lumbar Cage System is MAX.

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Fonte oficial

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