Devices

VerSys Femoral Head Provisional

  • Modèle / numéro de série
    All lots distributed from lot 69998600 (2/20/1996) to present
  • Classification du dispositif
    Orthopedic Devices
  • 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
    00789502601 VerSys Femoral Head Provisional 26mm -3.5 || 00789502602 VerSys Femoral Head Provisional 26mm +0 || 00789502603 VerSys Femoral Head Provisional 26mm +3.5 || 00789502604 VerSys Femoral Head Provisional 26mm +7 || 00789502605 VerSys Femoral Head Provisional 26mm +10.5 || 12/14 Neck Taper || The provisional heads replicate final femoral implant geometry y and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
  • Manufacturer
    Zimmer, Inc.
  • 2 Events

Fabricant

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • 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