{
  "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": "2026-07-27",
    "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": "QPQ",
      "openfda": {
        "k_number": [
          "DEN200039"
        ],
        "registration_number": [
          "3008729892",
          "2936485",
          "3016573902"
        ],
        "fei_number": [
          "2936485",
          "3016573902",
          "3002807555"
        ]
      },
      "review_panel": "OR",
      "medical_specialty": "OR",
      "device_name": "Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable,  Non-Fixed",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Orthopedic",
      "device_class": "2",
      "definition": "A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.",
      "regulation_number": "888.3630",
      "implant_flag": "Y",
      "submission_type_id": "1"
    }
  ]
}