M/DN Intramedullary Fixation

  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
  • Product Description
    INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. || Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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

30 devices with a similar name

Learn more about the data here

  • Model / Serial
    LOTS: 63295051 63293672
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
  • Product Description
    M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 || M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
  • Manufacturer
  • Model / Serial
    Lot Number: 63329859
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Product Description
    M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, Nonsterile
  • Manufacturer
  • Model / Serial
    Lot Number: 63562128
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Product Description
    M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137, Nonsterile
  • Manufacturer
  • Model / Serial
    Lot Numbers: 63616770, 63616771, 63616772, 63413732, 63413734, 63413737, 63443859, 63443861, 63443836, 63469287, 63469288, 63469289, 63474646, 63474647, 63474648, 63511483, 63529994, 63529995, 63529996 & 63530003
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Product Description
    M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile
  • Manufacturer
  • Model / Serial
    Lot Numbers: 63574676, 63574677, 63574678, 63424385, 63451742, 63493677 & 63493680
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Product Description
    M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile
  • Manufacturer
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