FDA 510(k)

LINK Embrace Shoulder System - Reverse Configuration

N.º K: K200368 · 2021-02-05

Fecha de decisión2021-02-05

Código de productoPHX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

LINK Embrace Shoulder System - Reverse Configuration 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 2021-02-05 under 510(k) number K200368. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LINK Embrace Shoulder System - Reverse Configuration?

LINK Embrace Shoulder System - Reverse Configuration is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K200368.

When did LINK Embrace Shoulder System - Reverse Configuration receive FDA 510(k) clearance?

LINK Embrace Shoulder System - Reverse Configuration received FDA 510(k) clearance on 2021-02-05, under 510(k) number K200368.

Who is the listed applicant for LINK Embrace Shoulder System - Reverse Configuration?

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 Embrace Shoulder System - Reverse Configuration?

The FDA product code for LINK Embrace Shoulder System - Reverse Configuration is PHX.

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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

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Dispositivos relacionados (Código: PHX)

K260556Veritas Shoulder SystemRestor3D K261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversa Glénoide y Tornier Perform Reversa Glénoide Aumentada del Hombro SistemaStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SA K253992Veritas Reverse Total Shoulder SystemRestor3D K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

Fuente oficial

Ver en la base de datos de la FDA →

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