Computer assisted surgical device

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.
  • Manufacturers representative
    INTERMEDIC S.A.L.
  • Source
    RLMPH

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial No. RO10011, RO10014, RO13023 and RO13027
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AR, OH, MI, and TX
  • Product Description
    ROSA Surgical Device 2.5.8
  • Manufacturer
  • Model / Serial
    Serial No. RO10011 and RO10014
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including OH and MI Internationally to Canada, China, France, Germany, and Italy
  • Product Description
    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