Devices

Multiaxial Translating MIS Screw

  • Model / Serial
    14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029  14-501661 Rod Reducer Lots IT0015 IT0022 IT0023  14-501662 Counter Torque Lots IT0020 IT0021
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
  • Product Description
    Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. || 1)Screw Tower - REF 14-501660 || 2) Rod Reduce - REF 14-501661 || 3) Counter Torque - REF 14-501662
  • Manufacturer
    Ebi, Llc
  • 1 Event

Manufacturer

Ebi, Llc
  • Manufacturer Address
    Ebi, Llc, 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • 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