Biomet Spine, LLC

12 dispositivos en la base de datos

  • Modelo / Serial
    Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25, 2013 and TU00155: July 31, 2013
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed in PR and the states of NY, AZ, TN, TX, and CA.
  • Descripción del producto
    Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. || Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
  • Modelo / Serial
    Model 8630-0204 Lots TU00052, TU00052A, and TU00117
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to states of: AZ, CA, NY, TN, and TX including PR.
  • Descripción del producto
    Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 || Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
  • Modelo / Serial
    LOT Numbers: TU00053A, TU00053B and TU00118 Product Code: 86300205
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to states of: AZ, CA, NY, TN and TX including PR.
  • Descripción del producto
    Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. || Spinal Surgical Device.
  • Modelo / Serial
    LOT Numbers: L561968 and L570545 Product Code: 7703-1600
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed to TX, OH, NE and NY.
  • Descripción del producto
    Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a quantity of two Inserters. || The Inserter is for use as part of a Telluride System pedicle screw procedure.
  • Modelo / Serial
    Model #8734-2XXX, 8734-5XXX. Lot #L556219. Product Code: 8734-2060, CC Blade, 60mm 8734-2070, CC Blade, 70mm 8734-2080, CC Blade, 80mm 8734-2090, CC Blade, 90mm 8734-2100, CC Blade, 100mm 8734-2110, CC Blade, 110mm 8734-2120, CC Blade, 120mm 8734-2130, CC Blade, 130mm 8734-2140, CC Blade, 140mm 8734-2150, CC Blade, 150mm 8734-2160, CC Blade, 160mm 8734-2170, CC Blade, 170mm 8734-2180, CC Blade, 180mm 8734-5050, Posterior Blade, 50mm 8734-5060, Posterior Blade, 60mm 8734-5070, Posterior Blade, 70mm 8734-5080, Posterior Blade, 80mm 8734-5090, Posterior Blade, 90mm 8734-5100, Posterior Blade, 100mm 8734-5110, Posterior Blade, 110mm 8734-5120, Posterior Blade, 120mm 8734-5130, Posterior Blade, 130mm 8734-5140, Posterior Blade, 140mm 8734-5150, Posterior Blade, 150mm 8734-5160, Posterior Blade, 160mm 8734-5170, Posterior Blade, 170mm 8734-5180, Posterior Blade, 180mm
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed to TX, IN, MO, and NY. No foreign/govt/military/VA.
  • Descripción del producto
    Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure || Timberline Anchored Lateral Retractable Drills are used with the Timberline Lateral System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
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Más información acerca de la data acá

  • 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