FDA 510(k)

Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System

N.º K: K231114 · 2023-08-09

SolicitanteZimmer Switzerland Manufacturing GmbH

Fecha de decisión2023-08-09

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail 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 2023-08-09 under 510(k) number K231114. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System?

Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System is a medical device that received FDA 510(k) clearance on 2023-08-09. The listed applicant is Zimmer Switzerland Manufacturing GmbH. The 510(k) number is K231114.

When did Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System receive FDA 510(k) clearance?

Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System received FDA 510(k) clearance on 2023-08-09, under 510(k) number K231114.

Who is the listed applicant for Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail 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 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System?

The FDA product code for Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System is HSB.

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Otros registros que enlistan a Zimmer Switzerland Manufacturing GmbH como solicitante

K253749Affixus® Natural Nail® Proximal Humeral System K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate K212129Persona® Personalized Knee System

Dispositivos relacionados (Código: HSB)

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbH K253080Sistema de Clavo Femoral AND Medical (PFNA01); Sistema de Clavo Femoral AND Medical (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

Fuente oficial

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