FDA 510(k)

Origin™ Sistema de Placa Cervical Anterior

Número K: K193494 · 2020-04-06

RequerenteOrthopaedic & Spine Development

Data da decisão2020-04-06

Código do produtoKWQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Origin™ Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic & Spine Development. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K193494. 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 Origin™ Anterior Cervical Plate System?

Origin™ Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Orthopaedic & Spine Development. The 510(k) number is K193494.

When did Origin™ Anterior Cervical Plate System receive FDA 510(k) clearance?

Origin™ Anterior Cervical Plate System received FDA 510(k) clearance on 2020-04-06, under 510(k) number K193494.

Who is the listed applicant for Origin™ Anterior Cervical Plate System?

The FDA 510(k) record lists Orthopaedic & Spine Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Origin™ Anterior Cervical Plate System?

The FDA product code for Origin™ Anterior Cervical Plate System is KWQ.

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Fonte oficial

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