FDA 510(k)

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

N.º K: K200607 · 2021-05-28

Fecha de decisión2021-05-28

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Waldemar Link GmbH & Co. KG como solicitante

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)K250375Esbástil de Cadera Allure y Placas 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

Ver todos los 30 dispositivos →

Dispositivos relacionados (Código: LPH)

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Fuente oficial

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