{
  "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": "SDB",
      "openfda": {
        "k_number": [
          "DEN230087"
        ],
        "registration_number": [
          "3013847376"
        ],
        "fei_number": [
          "3013847376"
        ]
      },
      "review_panel": "AN",
      "medical_specialty": "AN",
      "device_name": "Tracheal Prosthesis With Cover Material Derived From Human Sources",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Anesthesiology",
      "device_class": "2",
      "definition": "The tracheal prosthesis with cover material derived from human sources is an expandable tubular device made of a metal material covered with a human-sourced decellularized material. It is intended to be implanted to restore the structure and/or function of the trachea or tracheobronchial tree. This device may also include a device delivery system. This device type does not include products that are intended to promote regeneration, impede inflammatory cascades, and release growth factors.",
      "regulation_number": "868.3721",
      "implant_flag": "Y",
      "submission_type_id": "1"
    }
  ]
}