FDA 510(k)

Skyway Anterior Cervical Plate System

Número K: K243015 · 2024-11-05

RequerenteKyocera Medical Technologies, Inc.

Data da decisão2024-11-05

Código do produtoKWQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Skyway Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K243015. 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 Skyway Anterior Cervical Plate System?

Skyway Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K243015.

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

Skyway Anterior Cervical Plate System received FDA 510(k) clearance on 2024-11-05, under 510(k) number K243015.

Who is the listed applicant for Skyway Anterior Cervical Plate System?

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

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

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

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Fonte oficial

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