MIS Slotted Femoral Head Provisional

  • Modèle / numéro de série
    All lots including lot 78939000 (1/7/2002) to present
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
  • Description du dispositif
    00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 || 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 || 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 || The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    All lots distributed from lot 69998600 (2/20/1996) to present
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.
  • Description du dispositif
    00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 || 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 || 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 || 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 || 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 || The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
  • Manufacturer