FDA 510(k)

MobileLink Acetabular Cup System - inhouse coatings

Número K: K243927 · 2025-05-16

Data da decisão2025-05-16

Código do produtoLZO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MobileLink Acetabular Cup System - inhouse coatings 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 2025-05-16 under 510(k) number K243927. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MobileLink Acetabular Cup System - inhouse coatings?

MobileLink Acetabular Cup System - inhouse coatings is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K243927.

When did MobileLink Acetabular Cup System - inhouse coatings receive FDA 510(k) clearance?

MobileLink Acetabular Cup System - inhouse coatings received FDA 510(k) clearance on 2025-05-16, under 510(k) number K243927.

Who is the listed applicant for MobileLink Acetabular Cup System - inhouse coatings?

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 MobileLink Acetabular Cup System - inhouse coatings?

The FDA product code for MobileLink Acetabular Cup System - inhouse coatings is LZO.

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Fonte oficial

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