FDA 510(k)

LINK Embrace Shoulder System- Anatomical Configuration

N.º K: K210899 · 2021-06-21

Fecha de decisión2021-06-21

Código de productoKWT

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

LINK Embrace Shoulder System- Anatomical 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 2021-06-21 under 510(k) number K210899. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LINK Embrace Shoulder System- Anatomical Configuration?

LINK Embrace Shoulder System- Anatomical Configuration is a medical device that received FDA 510(k) clearance on 2021-06-21. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K210899.

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

LINK Embrace Shoulder System- Anatomical Configuration received FDA 510(k) clearance on 2021-06-21, under 510(k) number K210899.

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

The FDA product code for LINK Embrace Shoulder System- Anatomical Configuration is KWT.

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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: KWT)

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944Sistema de Reemplazo de Hombro AGILON® XOImplantcast GmbH K241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657Sistema de Reemplazo de Hombro AGILON® XOImplantcast GmbH

Fuente oficial

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