ROSA Brain

  • Model / Serial
  • Product Description
    Alert removed device pink brain medtech
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    HA

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial #'s: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023 and BR16025.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.
  • Product Description
    MEDTECH ROSA Brain 3.0 || 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 neurological procedure in which the use of stereotactic surgery may be appropriate.
  • Manufacturer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: ROSA Brain 3.0.0 Robotic Surgical Assistant
  • Manufacturer
  • Model / Serial
    ROSA Brain 3.0.0 | BR16027; BR16029
  • Product Description
    MD: Neurological stereotactic surgery system
  • Manufacturer
  • Model / Serial
    ROSA Brain 3.0.0 Robotic Surgical AssistantSerial Number: BR15002ARTG Number: 235379
  • Manufacturer
  • Model / Serial
    ROSA Brain and ROSA One Surgical RobotsROSA Brain 3.0.0 Robotic Surgical AssistantSerial Number: BR15002ROSA One 3.1.0 Robotic Surgical AssistantSerial Number: BS16001ARTG Number: 235379 and 278903
  • Manufacturer
One more