FDA 510(k)

LINK Embrace Shoulder System - Reverse Configuration

Número K: K231445 · 2023-11-16

Data da decisão2023-11-16

Código do produtoPHX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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 2023-11-16 under 510(k) number K231445. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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 2023-11-16. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K231445.

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 2023-11-16, under 510(k) number K231445.

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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Outros registros que listam Waldemar Link GmbH & Co. KG como candidato(a)

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)K250375Allure Cadeira de Quadril e Plugs Intramedulares K243927MobileLink Acetabular Cup System - inhouse coatings K241636MobileLink Acetabular Cup System - Line Extension (Multiple)K222066LINK MobileLink Acetabular Cup System K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

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Dispositivos Relacionados (Código: PHX)

K260556Veritas Shoulder SystemRestor3D K261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid e Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SA K253992Veritas Reverse Total Shoulder SystemRestor3D K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

Fonte oficial

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