TRABECULAR METAL MODULAR ACETABULAR SYSTEM

  • Modèle / numéro de série
    00-6202-060-22; lot 62490588
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) in states of: US: GA, WI, NJ, CA, NY, NC, PA, FL, CT, ME, TX, and IL; and countries of: Australia and Canada.
  • Description du dispositif
    TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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

3 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    61091653
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution:USA including states of: MI, IN, WI, MO, CA, VA, MD, TX, NC, PA, OR, WA, FL, GA, NY, ME, AZ, and UT and country including Canada.
  • Description du dispositif
    Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog 00-6202-056-22, Zimmer Inc., Warsaw, IN. || This device is indicated for primary or revision surgery for rehabilitating hips damaged as the result of noninflammatory degenerative joint disease, including osteoarthritis, fused hip, avascular necrosis, traumatic arthritis and fracture of the pelvis.
  • Manufacturer
  • Modèle / numéro de série
    00-6202-052-21 | 61132698
  • Description du dispositif
    MD: Acetabulum prosthesis
  • Manufacturer
  • Modèle / numéro de série
    Part 00-6202-052-21, Lot 61132698 and lot 001122467
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, NC,NY, PA, WA, and WI and countries of Australia, Germany, The Netherlands, and Switzerland.
  • Description du dispositif
    The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty. || The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis,protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use.
  • Manufacturer