FDA 510(k)

Medline UNITE® REFLEX® Hybrid Nitinol Implant System

N.º K: K243888 · 2025-04-11

Fecha de decisión2025-04-11

Código de productoJDR

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medline UNITE® REFLEX® Hybrid Nitinol Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K243888. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medline UNITE® REFLEX® Hybrid Nitinol Implant System?

Medline UNITE® REFLEX® Hybrid Nitinol Implant System is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Medline Industries, LP. The 510(k) number is K243888.

When did Medline UNITE® REFLEX® Hybrid Nitinol Implant System receive FDA 510(k) clearance?

Medline UNITE® REFLEX® Hybrid Nitinol Implant System received FDA 510(k) clearance on 2025-04-11, under 510(k) number K243888.

Who is the listed applicant for Medline UNITE® REFLEX® Hybrid Nitinol Implant System?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline UNITE® REFLEX® Hybrid Nitinol Implant System?

The FDA product code for Medline UNITE® REFLEX® Hybrid Nitinol Implant System is JDR.

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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.