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FDA 510(k)

Responsive Orthopedics Total Hip Arthroplasty System

N.º K: K163585 · 2017-06-02

SolicitanteResponsive Orthopedics, LLC
Fecha de decisión2017-06-02
Código de productoLZO
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Responsive Orthopedics Total Hip Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Orthopedics, LLC. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K163585. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Responsive Orthopedics Total Hip Arthroplasty System?

Responsive Orthopedics Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Responsive Orthopedics, LLC. The 510(k) number is K163585.

When did Responsive Orthopedics Total Hip Arthroplasty System receive FDA 510(k) clearance?

Responsive Orthopedics Total Hip Arthroplasty System received FDA 510(k) clearance on 2017-06-02, under 510(k) number K163585.

Who is the listed applicant for Responsive Orthopedics Total Hip Arthroplasty System?

The FDA 510(k) record lists Responsive Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Responsive Orthopedics Total Hip Arthroplasty System?

The FDA product code for Responsive Orthopedics Total Hip Arthroplasty System is LZO.

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Dispositivos relacionados (Código: LZO)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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