Zimmer Manufacturing B.V.

90 dispositifs dans la base de données

  • Modèle / numéro de série
    Item No. 00-6200-054-20; Lot 62714305
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: France, Germany, Iran, Romania, Serbia, Singapore, Taiwan, and United Kingdom.
  • Description du dispositif
    Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD || The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of 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.
  • Modèle / numéro de série
    Lot No. 62629432 Lot No. 62628759
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada.
  • Description du dispositif
    Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.
  • Modèle / numéro de série
    LOTS: 63284570 63284572 63284573 63187350 63225662 63272712 63296123 63301504 63204283 63209528 63259476 63257719
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
  • Description du dispositif
    Trilogy self-tapping bone screw || Bone screw 4.5x25 selftap 00625004525 || Bone screw 4.5x50 selftap 00625004550 || Bone screw 6.5x15 selftap 00625006515 || Bone screw 6.5x20 selftap 00625006520 || Bone screw 6.5x25 selftap 00625006525 || Bone screw 6.5x30 selftap 00625006530
  • Modèle / numéro de série
    LOTS: 63276979 63276976 63245682 63276975 63276977 63301523 63276980 63303436
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
  • Description du dispositif
    Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 || Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 || Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 || Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 || Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 || Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560
  • Modèle / numéro de série
    LOT: 63290189
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
  • Description du dispositif
    VersaFx Femoral Fixation System || Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
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  • Adresse du fabricant
    Zimmer Manufacturing B.V.
  • 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