FDA 510(k)

Kodiak Lumbar Spacer System

Número K: K230851 · 2023-05-26

Data da decisão2023-05-26

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kodiak Lumbar Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Met One Technologies, LLC. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K230851. 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 Kodiak Lumbar Spacer System?

Kodiak Lumbar Spacer System is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Met One Technologies, LLC. The 510(k) number is K230851.

When did Kodiak Lumbar Spacer System receive FDA 510(k) clearance?

Kodiak Lumbar Spacer System received FDA 510(k) clearance on 2023-05-26, under 510(k) number K230851.

Who is the listed applicant for Kodiak Lumbar Spacer System?

The FDA 510(k) record lists Met One Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kodiak Lumbar Spacer System?

The FDA product code for Kodiak Lumbar Spacer System is MAX.

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Fonte oficial

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