FDA 510(k)

LINK MobileLink Acetabular Cup System

N.º K: K222066 · 2023-04-14

Fecha de decisión2023-04-14

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

LINK MobileLink Acetabular Cup System 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 2023-04-14 under 510(k) number K222066. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LINK MobileLink Acetabular Cup System?

LINK MobileLink Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K222066.

When did LINK MobileLink Acetabular Cup System receive FDA 510(k) clearance?

LINK MobileLink Acetabular Cup System received FDA 510(k) clearance on 2023-04-14, under 510(k) number K222066.

Who is the listed applicant for LINK MobileLink Acetabular Cup System?

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 MobileLink Acetabular Cup System?

The FDA product code for LINK MobileLink Acetabular Cup System is LPH.

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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 K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

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Dispositivos relacionados (Código: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.

Fuente oficial

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