FDA 510(k)

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters

Número K: K200607 · 2021-05-28

Data da decisão2021-05-28

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters 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 2021-05-28 under 510(k) number K200607. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters?

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K200607.

When did LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters receive FDA 510(k) clearance?

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters received FDA 510(k) clearance on 2021-05-28, under 510(k) number K200607.

Who is the listed applicant for LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters?

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 MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters?

The FDA product code for LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters is LPH.

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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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