FDA 510(k)

Tyber Medical Distal Radius Plating System

N.º K: K251361 · 2025-07-30

Fecha de decisión2025-07-30

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tyber Medical Distal Radius Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2025-07-30 under 510(k) number K251361. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tyber Medical Distal Radius Plating System?

Tyber Medical Distal Radius Plating System is a medical device that received FDA 510(k) clearance on 2025-07-30. The listed applicant is Tyber Medical, LLC. The 510(k) number is K251361.

When did Tyber Medical Distal Radius Plating System receive FDA 510(k) clearance?

Tyber Medical Distal Radius Plating System received FDA 510(k) clearance on 2025-07-30, under 510(k) number K251361.

Who is the listed applicant for Tyber Medical Distal Radius Plating System?

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

What is the FDA product code for Tyber Medical Distal Radius Plating System?

The FDA product code for Tyber Medical Distal Radius Plating System is HRS.

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Fuente oficial

Ver en la base de datos de la FDA →

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