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FDA 510(k)

Avanti Distal Elbow ORIF System

N.º K: K261145 · 2026-05-09

SolicitanteAvanti Orthopaedics, LLC
Fecha de decisión2026-05-09
Código de productoHRS
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Avanti Distal Elbow ORIF System is the device name listed in this FDA 510(k) record. The listed applicant is Avanti Orthopaedics, LLC. It received FDA 510(k) clearance on 2026-05-09 under 510(k) number K261145. 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 Avanti Distal Elbow ORIF System?

Avanti Distal Elbow ORIF System is a medical device that received FDA 510(k) clearance on 2026-05-09. The listed applicant is Avanti Orthopaedics, LLC. The 510(k) number is K261145.

When did Avanti Distal Elbow ORIF System receive FDA 510(k) clearance?

Avanti Distal Elbow ORIF System received FDA 510(k) clearance on 2026-05-09, under 510(k) number K261145.

Who is the listed applicant for Avanti Distal Elbow ORIF System?

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

What is the FDA product code for Avanti Distal Elbow ORIF System?

The FDA product code for Avanti Distal Elbow ORIF System is HRS.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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