FDA 510(k)

Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System

Número K: K231114 · 2023-08-09

RequerenteZimmer Switzerland Manufacturing GmbH

Data da decisão2023-08-09

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Switzerland Manufacturing GmbH. It received FDA 510(k) clearance on 2023-08-09 under 510(k) number K231114. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System?

Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System is a medical device that received FDA 510(k) clearance on 2023-08-09. The listed applicant is Zimmer Switzerland Manufacturing GmbH. The 510(k) number is K231114.

When did Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System receive FDA 510(k) clearance?

Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System received FDA 510(k) clearance on 2023-08-09, under 510(k) number K231114.

Who is the listed applicant for Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System?

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

What is the FDA product code for Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System?

The FDA product code for Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System is HSB.

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Dispositivos Relacionados (Código: HSB)

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Fonte oficial

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