FDA 510(k)

LINK TrabecuLink Femoral Cones

Número K: K201364 · 2020-07-17

Data da decisão2020-07-17

Código do produtoMBH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

LINK TrabecuLink Femoral Cones is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K201364. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LINK TrabecuLink Femoral Cones?

LINK TrabecuLink Femoral Cones is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K201364.

When did LINK TrabecuLink Femoral Cones receive FDA 510(k) clearance?

LINK TrabecuLink Femoral Cones received FDA 510(k) clearance on 2020-07-17, under 510(k) number K201364.

Who is the listed applicant for LINK TrabecuLink Femoral Cones?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINK TrabecuLink Femoral Cones?

The FDA product code for LINK TrabecuLink Femoral Cones is MBH.

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Outros registros que listam Waldemar Link GmbH & Co. KG como candidato(a)

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)K250375Allure Cadeira de Quadril e Plugs Intramedulares K243927MobileLink Acetabular Cup System - inhouse coatings K241636MobileLink Acetabular Cup System - Line Extension (Multiple)K231445LINK Embrace Shoulder System - Reverse Configuration K222066LINK MobileLink Acetabular Cup System

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Fonte oficial

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