Affixus Intramedullary Hip Fracture Nail

  • Modelo / Serial
    Item No. 814611460; Lot No. (Exp. Date) UDI: 555810 (05/27/2027) UDI (01)00887868039867 (17)270527 (10)555810; 788580 (07/17/2027) UDI (01)00887868039867 (17)270717 (10)788580
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US nationwide distribution. Also Portugal and the Netherlands.
  • Descripción del producto
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

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Más información acerca de la data acá

  • Modelo / Serial
    Item No. 814613460; Lot No. (Exp. Date) UDI: 862150 (06/15/2027) UDI (01)00887868039980 (17)270615 (10)862150
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US nationwide distribution. Also Portugal and the Netherlands.
  • Descripción del producto
    Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM
  • Manufacturer
  • Modelo / Serial
    Item No. 814309180, Lot No. 459250, Exp. Date 05/27/2027, UDI (01)00887868037962 (17)270527 (10)459250
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US nationwide distribution. Also Portugal and the Netherlands.
  • Descripción del producto
    Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM
  • Manufacturer
  • Modelo / Serial
    Item No. 814511180, Lot No. 459170, Exp. Date 05/18/2027, (01)00887868039102 (17)270518 (10)459170
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US nationwide distribution. Also Portugal and the Netherlands.
  • Descripción del producto
    Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM
  • Manufacturer
  • Modelo / Serial
    Item No. 814509180, Lot No. 459290, Exp. Date 05/17/2027, (01)00887868038846 (17)270517 (10)459290
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US nationwide distribution. Also Portugal and the Netherlands.
  • Descripción del producto
    Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
  • Manufacturer
  • Modelo / Serial
    Item No. 814609280; Lot No. (Exp. Date) UDI: 936100 (06/15/2027) UDI (01)00887868039669 (17)270615 (10)936100
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US nationwide distribution. Also Portugal and the Netherlands.
  • Descripción del producto
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM
  • Manufacturer
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