Vanguard Complete Knee System

  • Modelo / Serial
    Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to states of: FL, WI, MD, MO, and MI.
  • Descripción del producto
    Vanguard CR Porous Femoral 62.5mm (Left Femur) || For use in total knee arthroplasty
  • 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

4 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lots 198810 and 210320
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed to accounts in CA, CT, GA, IA, IN, LA, MA, MD, MN, MS, NJ, OH, PA, TN, TX, UT, VA, WI. Foreign distribution to Taiwan, Japan, and the Netherlands.
  • Descripción del producto
    Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 || Product Usage: The product is intended for use in knee joint replacement arthroplasties.
  • Manufacturer
  • Modelo / Serial
    Item Number 184108 Lot Number 183410 Exp. 8/27/2025
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide in the states of NJ, MI, FL and the countries of Sweden and Canada.
  • Descripción del producto
    Vanguard Distal Femoral Augment 75 X 5 RL/LM || Product Usage: || Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.  Correction of varus, valgus, or posttraumatic deformity.  Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.  The device is a single use implant intended for implantation with bone cement.
  • Manufacturer
  • Modelo / Serial
    Lot Number: 388680, Exp. Date 5/19/2022
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands
  • Descripción del producto
    Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 || Product Usage: || For use in total knee arthroplasty
  • Manufacturer
  • Modelo / Serial
    Lot Number: 473290, Exp. Date 5/19/2022
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands
  • Descripción del producto
    Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 || Product Usage: || For use in total knee arthroplasty
  • Manufacturer