Bone Plate

  • Model / Serial
    Lot 193690
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution including the states of: California and Texas.
  • Product Description
    Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-LONG, 0.6 MM TITANIUM, BIOMET MICROFIXATION, 1540 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, 01-736, LOT 999999, QTY 00001, L-SHAPE, 3 X 3 HOLE, 100 DEGREE, LEFT, X-LONG, 0.6 MM, CE 0086.***" || Product Usage - CTS Usage: || Bone-plate - internal fixation devices intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomet Microfixation, LLC, 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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

14 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lots 634570 and 802070.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
  • Product Description
    ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-140.
  • Manufacturer
  • Model / Serial
    Lots 796010 and 634540.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
  • Product Description
    ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-123.
  • Manufacturer
  • Model / Serial
    Lots 634550, 796050 and 796040.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
  • Product Description
    ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-125.
  • Manufacturer
  • Model / Serial
    Lots 634560 and 802080.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
  • Product Description
    ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-127.
  • Manufacturer
  • Model / Serial
    Lots 634580, 796070, 857390, 796030, 802090 and 878300.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
  • Product Description
    ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-142.
  • Manufacturer
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