Biomet Spine, LLC

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Description

12 dispositivos en la base de datos

  • Modelo / Serial
    P/N: 14-521550; Lot Numbers: 463870;  P/N: 14-521548; Lot Numbers: J86056;  P/N: 14-521518; Lot Numbers: J26394; Model Numbers: 14-521518 14-521520 14-521548 14-521550
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to the states of : NY, MO, and FL
  • Descripción del producto
    MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
  • Modelo / Serial
    Model Number 14-521614B, lot number 375440.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA.
  • Descripción del producto
    Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
  • Modelo / Serial
    P/N1400-1230 from Lot#2350871 from either loose inventory or Kit 555000162, Date of Manufacture: April 16, 2013
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide - one foreign consignee (not Canada).
  • Descripción del producto
    10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Model Number 1400-1230. || Product Usage: || The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the SOLITAIRETM ANTERIOR SPINAL SYSTEM is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SolitaireTM System is also indicated for treating fractures of the thoracic and lumbar spine. The SolitaireTM System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
  • Modelo / Serial
    P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) in states of: NY, MO, WI, IN, CA, NC, and OH, and to countries of: Japan and Netherlands.
  • Descripción del producto
    Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. || The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.
  • Modelo / Serial
    538133,538134,548080,550475,552169,553131,553710,558873,567568,569141  Part Number: 6200-1109 2009300344 to 2009300543  2009300544 to 2009300643  2009300644 to 2009300743  2009300744 to 2009300843  2009300844 to 2009300993  2009411328 to 2009411377  2010082160 to 2010082257  2010152507 to 2010152571  2010373025 to 2010373174
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide
  • Descripción del producto
    Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 || Product Usage: || Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
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  • Dirección del fabricante
    Biomet Spine, 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