{
  "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,
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  "results": [
    {
      "proprietary_name": [
        "Avalign Delivery Systems does not manufacture thoracolumbosacral pedicle screw system. The listing has been made",
        "because Medtronic cases and trays are registered as accessories to the thoracolumbosacral pedicle screw system in K15228"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "1835444",
        "fei_number": "3000717687",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Avalign Delivery Systems Division",
        "address_line_1": "2121 SOUTHTECH DRIVE",
        "address_line_2": "SUITE 600",
        "city": "Greenwood",
        "state_code": "IN",
        "iso_country_code": "US",
        "zip_code": "46143",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "Avalign Delivery Systems Division",
          "owner_operator_number": "9026184",
          "official_correspondent": {
            "first_name": "Thomas",
            "middle_initial": "",
            "last_name": "Clyne",
            "subaccount_company_name": "",
            "phone_number": "x-317-8592300-x"
          },
          "contact_address": {
            "address_1": "2121 Southtech Drive",
            "address_2": "Suite 600",
            "city": "Greenwood",
            "state_code": "IN",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "46143"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "KWP",
          "created_date": "2023-09-18",
          "owner_operator_number": "9026184",
          "exempt": "",
          "openfda": {
            "device_name": "Appliance, Fixation, Spinal Interlaminal",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3050",
            "device_class": "2"
          }
        },
        {
          "product_code": "KWQ",
          "created_date": "2023-09-18",
          "owner_operator_number": "9026184",
          "exempt": "",
          "openfda": {
            "device_name": "Appliance, Fixation, Spinal Intervertebral Body",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3060",
            "device_class": "2"
          }
        },
        {
          "product_code": "NKB",
          "created_date": "2023-09-18",
          "owner_operator_number": "9026184",
          "exempt": "",
          "openfda": {
            "device_name": "Thoracolumbosacral Pedicle Screw System",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3070",
            "device_class": "2"
          }
        },
        {
          "product_code": "MNH",
          "created_date": "2023-09-18",
          "owner_operator_number": "9026184",
          "exempt": "",
          "openfda": {
            "device_name": "Orthosis, Spondylolisthesis Spinal Fixation",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3070",
            "device_class": "2"
          }
        },
        {
          "product_code": "OSH",
          "created_date": "2023-09-18",
          "owner_operator_number": "9026184",
          "exempt": "",
          "openfda": {
            "device_name": "Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3070",
            "device_class": "2"
          }
        },
        {
          "product_code": "MNI",
          "created_date": "2023-09-18",
          "owner_operator_number": "9026184",
          "exempt": "",
          "openfda": {
            "device_name": "Orthosis, Spinal Pedicle Fixation",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3070",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}