FDA 510(k)

MUTARS® femoral stem cemented 160 mm and 200 mm

Número K: K240391 · 2024-10-24

Data da decisão2024-10-24

Código do produtoLZO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MUTARS® femoral stem cemented 160 mm and 200 mm is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K240391. 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 MUTARS® femoral stem cemented 160 mm and 200 mm?

MUTARS® femoral stem cemented 160 mm and 200 mm is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Implantcast GmbH. The 510(k) number is K240391.

When did MUTARS® femoral stem cemented 160 mm and 200 mm receive FDA 510(k) clearance?

MUTARS® femoral stem cemented 160 mm and 200 mm received FDA 510(k) clearance on 2024-10-24, under 510(k) number K240391.

Who is the listed applicant for MUTARS® femoral stem cemented 160 mm and 200 mm?

The FDA 510(k) record lists Implantcast GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MUTARS® femoral stem cemented 160 mm and 200 mm?

The FDA product code for MUTARS® femoral stem cemented 160 mm and 200 mm is LZO.

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Outros registros que listam Implantcast GmbH como candidato(a)

K252451EPORE® XO cup system K260037implantcast Packaging System Update K252401implaFit® short stems K241944Sistema de Re Replacement de Ombro AGILON® XO K234044Sistema de Quadril ACS® LD FB K240834EcoFit® short stem cementless cpTi

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Dispositivos Relacionados (Código: LZO)

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG K260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

Fonte oficial

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