ARRAY and POLARIS Spinal System

  • Model / Serial
    Part number: 94672; Packaged lot number Product marked Lot # ( on device) 417400 415320 626740 624600 634130 629020
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: USA and the countries of Australia, Columbia, Great Britain, The Netherlands, New Zealand, and Switzerland.
  • Product Description
    ARRAY and POLARIS Spinal System Medium Cross Connector || Non Sterile || Biomet Spine, Parsippany, NJ. 07054
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ebi, Llc, 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • 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
    USFDA