Porous Plasma Spray (PPS) Ringloc Acetabular System

  • Modelo / Serial
    Lot numbers M208530, M565150 and M726020.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • Descripción del producto
    Ringloc + Acetabular Shell limited hole finned 62 mm Size 26 porous coat, for uncemented use, sterile, REF 16-104162, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc ¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 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

26 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot number M181150, M582250, M582270, M964240 and M964260.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • Descripción del producto
    Ringloc + Acetabular Shell limited hole, 46 mm Size 22 porous coat, for uncemented use, sterile, REF 16-116046, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc ¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • Modelo / Serial
    Lot numbers M116440, M482360 and M971640.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • Descripción del producto
    Ringloc + Acetabular Shell limited hole, 48 mm Size 22, porous coat, for uncemented use, sterile, REF 16-116048, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc ¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • Modelo / Serial
    Lot numbers M815760 and M883550.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • Descripción del producto
    Ringloc + Acetabular Shell limited hole, 50 mm Size 23, porous coat, for uncemented use, sterile, REF 16-116050, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc ¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • Modelo / Serial
    Lot numbers M181200, M686190, M883600 and M163280.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • Descripción del producto
    Ringloc + Acetabular Shell limited hole, 52 mm Size 23, porous coat, for uncemented use, sterile, REF 16-116052, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc ¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • Modelo / Serial
    Lot numbers M181350, M181360 and M971730.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • Descripción del producto
    Ringloc + Acetabular Shell limited hole, 54 mm Size 24, porous coat, for uncemented use, sterile, REF 16-116054, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc ¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
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