FDA 510(k)

LINK MobileLink Acetabular Cup System

Número K: K222066 · 2023-04-14

Data da decisão2023-04-14

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

LINK MobileLink Acetabular Cup System 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 2023-04-14 under 510(k) number K222066. 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?

LINK MobileLink Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K222066.

When did LINK MobileLink Acetabular Cup System receive FDA 510(k) clearance?

LINK MobileLink Acetabular Cup System received FDA 510(k) clearance on 2023-04-14, under 510(k) number K222066.

Who is the listed applicant for LINK MobileLink Acetabular Cup System?

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?

The FDA product code for LINK MobileLink Acetabular Cup System 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 K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

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Fonte oficial

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