{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 219
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spina"
      ],
      "establishment_type": [
        "Complaint File Establishment per 21 CFR 820.198",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "2183449",
        "fei_number": "2183449",
        "status_code": "1",
        "initial_importer_flag": "Y",
        "reg_expiry_date_year": "2027",
        "name": "ORTHOFIX US LLC",
        "address_line_1": "3451 Plano Parkway",
        "address_line_2": "",
        "city": "Lewisville",
        "state_code": "TX",
        "iso_country_code": "US",
        "zip_code": "75056",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "Orthofix US LLC",
          "owner_operator_number": "10028162",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "3451 Plano Parkway",
            "address_2": "",
            "city": "Lewisville",
            "state_code": "TX",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "75056"
          }
        }
      },
      "pma_number": "",
      "k_number": "K171082",
      "products": [
        {
          "product_code": "KWP",
          "created_date": "2017-05-19",
          "owner_operator_number": "10028162",
          "exempt": "",
          "openfda": {
            "device_name": "Appliance, Fixation, Spinal Interlaminal",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3050",
            "device_class": "2"
          }
        },
        {
          "product_code": "NKB",
          "created_date": "2017-05-19",
          "owner_operator_number": "10028162",
          "exempt": "",
          "openfda": {
            "device_name": "Thoracolumbosacral Pedicle Screw System",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3070",
            "device_class": "2"
          }
        },
        {
          "product_code": "KWQ",
          "created_date": "2017-05-19",
          "owner_operator_number": "10028162",
          "exempt": "",
          "openfda": {
            "device_name": "Appliance, Fixation, Spinal Intervertebral Body",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3060",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}