FDA 510(k)

Sistema de Nivelación de Tíbia y Fémur Antegrado Affixus

N.º K: K241651 · 2024-09-26

Fecha de decisión2024-09-26

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Affixus Tibial and Antegrade Femoral Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2024-09-26 under 510(k) number K241651. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Affixus Tibial and Antegrade Femoral Nailing System?

Affixus Tibial and Antegrade Femoral Nailing System is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Zimmer, Inc.. The 510(k) number is K241651.

When did Affixus Tibial and Antegrade Femoral Nailing System receive FDA 510(k) clearance?

Affixus Tibial and Antegrade Femoral Nailing System received FDA 510(k) clearance on 2024-09-26, under 510(k) number K241651.

Who is the listed applicant for Affixus Tibial and Antegrade Femoral Nailing System?

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

What is the FDA product code for Affixus Tibial and Antegrade Femoral Nailing System?

The FDA product code for Affixus Tibial and Antegrade Femoral Nailing System is HSB.

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Fuente oficial

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