Devices

ComputerAssisted Surgical Device

  • Modelo / Serial
    Device Listing No. D264591, Serial No. BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16024.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including CA, FL, MA, MN, NC, NY, OH, PA, DC; Foreign - Australia, and France
  • Descripción del producto
    ROSA Brain, 3.0.0 || The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event

Fabricante

Zimmer Biomet, Inc.
  • Dirección del fabricante
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • 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

8 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall ComputerAssisted Surgical Device
  • Modelo / Serial
    Model Number: ROSA 2.5.8
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to OH, MI, and TX
  • Descripción del producto
    ROSA Surgical Device 2.5.8 || ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ROSA ComputerAssisted Surgical Device
  • Modelo / Serial
    Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US distribution in AR, GA, OH, MI, and TX.
  • Descripción del producto
    ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ComputerAssisted Surgical Device
  • Modelo / Serial
    Serial No. BR16017 and BR16018
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    OH and PA.
  • Descripción del producto
    ROSA BRAIN 3.0.0
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ComputerAssisted Surgical Device
  • Modelo / Serial
    Serial No. BR16004, BR15002, and BR15003
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (DC) and Internationally to Australia and France.
  • Descripción del producto
    ROSA Brain 3.0 || Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ComputerAssisted Surgical Device
  • Modelo / Serial
    Serial No. RO10011, RO14033, RO14031, RO14035, RO13027, RO13023, RO10014, RO10009, RO10010, RO14030, RO11016, RO11017, RO12022, RO14029, RO14032, RO08003, RO09004, RO10007, RO10013, RO12018, RO12019, RO13025, RO14034, RO11015, RO13024, RO09005, RO13026, RO12021, and RO12020.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.
  • Descripción del producto
    ROSA Surgical Device 2.5.8 || It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
  • Manufacturer
    Zimmer Biomet, Inc.
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