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FDA 510(k)

Implante de Articulación Radio-Ulnar Distal de Aptis Medical

N.º K: K190599 · 2019-05-03

SolicitanteAptis Medical, LLC
Fecha de decisión2019-05-03
Código de productoKXE
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Aptis Medical Distal Radio Ulnar Joint Implant is the device name listed in this FDA 510(k) record. The listed applicant is Aptis Medical, LLC. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K190599. The device is classified under product code KXE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Aptis Medical Distal Radio Ulnar Joint Implant?

Aptis Medical Distal Radio Ulnar Joint Implant is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Aptis Medical, LLC. The 510(k) number is K190599.

When did Aptis Medical Distal Radio Ulnar Joint Implant receive FDA 510(k) clearance?

Aptis Medical Distal Radio Ulnar Joint Implant received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190599.

Who is the listed applicant for Aptis Medical Distal Radio Ulnar Joint Implant?

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

What is the FDA product code for Aptis Medical Distal Radio Ulnar Joint Implant?

The FDA product code for Aptis Medical Distal Radio Ulnar Joint Implant is KXE.

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Fuente oficial

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