Uniflex Humeral Nail

  • Modèle / numéro de série
    Item Number 467265 Lot Number 662420
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to states of: MD,TX, FL, GA, VA and PA.
  • Description du dispositif
    Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK || Pin, Fixation, Smooth || A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant into the humeral canal after the fracture has been reduced.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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