FDA 510(k)

Persona® Personalized Knee System

Número K: K212129 · 2021-09-28

RequerenteZimmer Switzerland Manufacturing GmbH

Data da decisão2021-09-28

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Persona® Personalized Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Switzerland Manufacturing GmbH. It received FDA 510(k) clearance on 2021-09-28 under 510(k) number K212129. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Persona® Personalized Knee System?

Persona® Personalized Knee System is a medical device that received FDA 510(k) clearance on 2021-09-28. The listed applicant is Zimmer Switzerland Manufacturing GmbH. The 510(k) number is K212129.

When did Persona® Personalized Knee System receive FDA 510(k) clearance?

Persona® Personalized Knee System received FDA 510(k) clearance on 2021-09-28, under 510(k) number K212129.

Who is the listed applicant for Persona® Personalized Knee System?

The FDA 510(k) record lists Zimmer Switzerland Manufacturing GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Persona® Personalized Knee System?

The FDA product code for Persona® Personalized Knee System is JWH.

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Outros registros que listam Zimmer Switzerland Manufacturing GmbH como candidato(a)

K253749Sistema Proximal de Humeral da Unha Natural Affixus®K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System

Dispositivos Relacionados (Código: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Sistema de Quadril de RevisãoDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Fonte oficial

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