{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 11
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Apex Tibial Nailing System Instrumentation"
      ],
      "establishment_type": [
        "Manufacture Medical Device",
        "Complaint File Establishment per 21 CFR 820.198",
        "Develop Specifications But Do Not Manufacture At This Facility"
      ],
      "registration": {
        "registration_number": "3014976005",
        "fei_number": "3014976005",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "ORTHOXEL",
        "address_line_1": "Cube House, Cork Business and Technology Park, Model Farm Road",
        "address_line_2": "Bishopstown",
        "city": "Cork Cork(City)",
        "state_code": "",
        "iso_country_code": "IE",
        "zip_code": "",
        "postal_code": "T12 H966",
        "us_agent": {
          "name": "Hannah Irwin",
          "business_name": "MCRA, LLC",
          "bus_phone_area_code": "202",
          "bus_phone_num": "5525820",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "hirwin@mcra.com",
          "address_line_1": "803 7th St Nw Fl 3",
          "address_line_2": "",
          "city": "Washington",
          "state_code": "DC",
          "iso_country_code": "US",
          "zip_code": "20001",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "OrthoXel",
          "owner_operator_number": "10058878",
          "official_correspondent": {
            "first_name": "Mark",
            "middle_initial": "",
            "last_name": "Moynihan",
            "subaccount_company_name": "",
            "phone_number": "353-21-2429500-x"
          },
          "contact_address": {
            "address_1": "Cube House,",
            "address_2": "Cork Business and Technology Park, Model Farm Road",
            "city": "Cork",
            "state_code": "IE-NOTA",
            "state_province": "",
            "iso_country_code": "IE",
            "postal_code": "T12 H966"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "HTW",
          "created_date": "2019-09-26",
          "owner_operator_number": "10058878",
          "exempt": "",
          "openfda": {
            "device_name": "Bit, Drill",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.4540",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}