Versys

  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
  • Descripción del producto
    12/14 UNIPOLAR FEMORAL HE || VERSYS CEM LD/FX SZ 11X12 || VERSYS CEM LD/FX SZ 12X12 || VERSYS CEM LD/FX SZ 14X13 || VERSYS CEM LD/FX SZ 16X14 || VERSYS CEM LD/FX ST 18X15 || VERSYS PRESS FIT LD/FX ST || VERSYS PRESS FIT LD/FX SZ || VERSYS ADVOCATE CEMENTED || VERSYS ADVOCATE V-LIGN CE || VERSYS CEMENTED FEM STEM || VERSYS CT FEM STEM 11X120 || VERSYS CT FEM STEM 12X125 || VERSYS CT FEM STEM 13X130 || VERSYS CT FEM STEM 14X135 || VERSYS CT FEM STEM 15X140 || VERSYS CT FEM STEM 16X145 || VERSYS CT FEM STEM 17X150 || VERSYS CEM/REV/CALCAR 13X || VERSYS CEM/REV/CALCAR 15X || VERSYS CEM/REV/CALCAR 17X || VERSYS CEM/REV/CALCAR 19X
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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

72 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
  • Modelo / Serial
    Item numbers: 00-7843-011-16 00-7843-012-16 00-7843-013-16 00-7843-014-16 00-7843-015-16 00-7843-016-16 Lot numbers: 61760685 61781980 61840199 61844725 61844726 61951281 61956725 61968111 61987956 62011958 62029062 62034145 62097248 62097288 62120672
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
  • Descripción del producto
    VERSYS 6 INCH BEADED FC 1 || prosthesis, hip, semi-constrained, metal/polymer, porous uncemented || "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected."
  • Manufacturer
  • Modelo / Serial
    Item numbers: 00-7843-012-18 00-7843-013-18 00-7843-015-18 00-7843-015-24 00-7843-016-18 00-7843-016-24 00-7843-018-18 00-7843-018-24 00-7843-019-18 00-7843-019-24 00-7843-021-18 00-7843-021-24 00-7843-022-18 00-7843-022-24 Lot numbers: 11006277 61775244 61781982 61786860 61815081 61879442 61937678 61956718 61956722 61981808 61993659 62029064 62043111 62143772 77000810 77000822
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
  • Descripción del producto
    VERSYS 7.5 INCH BEADED FC || prosthesis, hip, semi-constrained, metal/polymer, porous uncemented || "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected."
  • Manufacturer
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