FDA 510(k)

Omnia Medical Rotary PLIF System

Número K: K183659 · 2019-02-06

Data da decisão2019-02-06

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Omnia Medical Rotary PLIF System is the device name listed in this FDA 510(k) record. The listed applicant is Omnia Medical, LLC. It received FDA 510(k) clearance on 2019-02-06 under 510(k) number K183659. 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 Omnia Medical Rotary PLIF System?

Omnia Medical Rotary PLIF System is a medical device that received FDA 510(k) clearance on 2019-02-06. The listed applicant is Omnia Medical, LLC. The 510(k) number is K183659.

When did Omnia Medical Rotary PLIF System receive FDA 510(k) clearance?

Omnia Medical Rotary PLIF System received FDA 510(k) clearance on 2019-02-06, under 510(k) number K183659.

Who is the listed applicant for Omnia Medical Rotary PLIF System?

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

What is the FDA product code for Omnia Medical Rotary PLIF System?

The FDA product code for Omnia Medical Rotary PLIF System is MAX.

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Fonte oficial

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