FDA 510(k)

LEGION Total Knee System

Número K: K250677 · 2025-04-02

Data da decisão2025-04-02

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

LEGION Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K250677. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LEGION Total Knee System?

LEGION Total Knee System is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K250677.

When did LEGION Total Knee System receive FDA 510(k) clearance?

LEGION Total Knee System received FDA 510(k) clearance on 2025-04-02, under 510(k) number K250677.

Who is the listed applicant for LEGION Total Knee System?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEGION Total Knee System?

The FDA product code for LEGION Total Knee System is JWH.

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Outros registros que listam Smith & Nephew, Inc. como candidato(a)

K261462LANDMARK Total Knee System K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084Sistema de Ombro AETOS - CONCELOC Glenoids K252416Prótese Metacôndila AETOS Shoulder System Size 0 K252129Prótese de Humeral AETOS Shoulder System Sem Cabeça K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Dispositivos Relacionados (Código: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Sistema de Quadril de RevisãoDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Fonte oficial

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