FDA 510(k)

Corelink Foundation 3D Anterior Lumbar System

Número K: K180556 · 2018-07-27

Data da decisão2018-07-27

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Corelink Foundation 3D Anterior Lumbar System is the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2018-07-27 under 510(k) number K180556. 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 Corelink Foundation 3D Anterior Lumbar System?

Corelink Foundation 3D Anterior Lumbar System is a medical device that received FDA 510(k) clearance on 2018-07-27. The listed applicant is Corelink, LLC. The 510(k) number is K180556.

When did Corelink Foundation 3D Anterior Lumbar System receive FDA 510(k) clearance?

Corelink Foundation 3D Anterior Lumbar System received FDA 510(k) clearance on 2018-07-27, under 510(k) number K180556.

Who is the listed applicant for Corelink Foundation 3D Anterior Lumbar System?

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

What is the FDA product code for Corelink Foundation 3D Anterior Lumbar System?

The FDA product code for Corelink Foundation 3D Anterior Lumbar System is MAX.

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Fonte oficial

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