Ebi, Llc

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Description

6 dispositivos en la base de datos

  • Modelo / Serial
    Part number: 94672; Packaged lot number Product marked Lot # ( on device) 417400 415320 626740 624600 634130 629020
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: USA and the countries of Australia, Columbia, Great Britain, The Netherlands, New Zealand, and Switzerland.
  • Descripción del producto
    ARRAY and POLARIS Spinal System Medium Cross Connector || Non Sterile || Biomet Spine, Parsippany, NJ. 07054
  • Modelo / Serial
    Multiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the  SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution including Puerto Rico.
  • Descripción del producto
    BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. || Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
  • Modelo / Serial
    Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
  • Descripción del producto
    Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
  • Modelo / Serial
    Device listing # D090878 Catalog # LV00407 Lot #184090
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to CA
  • Descripción del producto
    Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 || The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion
  • Modelo / Serial
    14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029  14-501661 Rod Reducer Lots IT0015 IT0022 IT0023  14-501662 Counter Torque Lots IT0020 IT0021
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
  • Descripción del producto
    Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. || 1)Screw Tower - REF 14-501660 || 2) Rod Reduce - REF 14-501661 || 3) Counter Torque - REF 14-501662
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Más información acerca de la data acá

  • Dirección del fabricante
    Ebi, Llc, 399 Jefferson Rd, Parsippany NJ 07054-3707
  • 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
  • Representante del fabricante
    Biomedic
  • Source
    RLMPH