{
  "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": "2026-10-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 443
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Invictus"
      ],
      "establishment_type": [
        "Manufacture Device in the United States for Export Only"
      ],
      "registration": {
        "registration_number": "1423662",
        "fei_number": "3000215273",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Sterigenics US LLC",
        "address_line_1": "1003 Lakeside Drive",
        "address_line_2": "",
        "city": "Gurnee",
        "state_code": "IL",
        "iso_country_code": "US",
        "zip_code": "60031",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "Sotera Health LLC",
          "owner_operator_number": "10029425",
          "official_correspondent": {
            "first_name": "Karen",
            "middle_initial": "",
            "last_name": "Whaley-Krumins",
            "subaccount_company_name": "",
            "phone_number": "x-630-9281700-x"
          },
          "contact_address": {
            "address_1": "2015 Spring Road",
            "address_2": "Suite 650",
            "city": "Oak Brook",
            "state_code": "IL",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "60523"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "NKB",
          "created_date": "2026-03-20",
          "owner_operator_number": "10029425",
          "exempt": "",
          "openfda": {
            "device_name": "Thoracolumbosacral Pedicle Screw System",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3070",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}