FDA 510(k)

Sistema de Unha Natural Affixus para Ombro

Número K: K181827 · 2018-12-14

Data da decisão2018-12-14

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Affixus Natural Nail System Humeral Nail is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K181827. 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 Affixus Natural Nail System Humeral Nail?

Affixus Natural Nail System Humeral Nail is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Zimmer GmbH. The 510(k) number is K181827.

When did Affixus Natural Nail System Humeral Nail receive FDA 510(k) clearance?

Affixus Natural Nail System Humeral Nail received FDA 510(k) clearance on 2018-12-14, under 510(k) number K181827.

Who is the listed applicant for Affixus Natural Nail System Humeral Nail?

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

What is the FDA product code for Affixus Natural Nail System Humeral Nail?

The FDA product code for Affixus Natural Nail System Humeral Nail is HSB.

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Outros registros que listam Zimmer GmbH como candidato(a)

K211047CoCr Head K200814Sistema de Unha Natural Affixus(R) Unha Humeral K200112Zimmer Hip Joint Replacement K193099Sistema de Ombro Anatômico K193050Fêmur Alloclassic Zweymuller SL, Fêmur Alloclassic Zweymuller SL com Desvio, Alloclassic Zweymuller SL K193030Avenir Muller Stem, Avenir Cemented Hip Stem

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Fonte oficial

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