{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QAD",
      "openfda": {
        "k_number": [
          "K233436",
          "K183145",
          "K201961",
          "DEN160062",
          "K202887",
          "K181228",
          "K200295"
        ],
        "registration_number": [
          "1222747",
          "3006845464"
        ],
        "fei_number": [
          "3006845464",
          "1000120776"
        ]
      },
      "review_panel": "OR",
      "medical_specialty": "OR",
      "device_name": "Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Orthopedic",
      "device_class": "2",
      "definition": "Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.  The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure.",
      "regulation_number": "888.3023",
      "implant_flag": "Y",
      "submission_type_id": "1"
    }
  ]
}