{
  "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": "2026-11-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "OMX",
      "openfda": {
        "registration_number": [
          "3003477135",
          "1649379",
          "1649833",
          "1020279"
        ],
        "fei_number": [
          "3003477135",
          "3000718490",
          "3001584317",
          "1020279"
        ]
      },
      "review_panel": "OR",
      "medical_specialty": "",
      "device_name": "High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "f",
      "definition": "For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient: a) has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction; and b) needs a revision of a failed PIP prosthesis, or has pain, limited motion, or joint subluxation/disloation secondary to damage or destruction of the articular cartilage.",
      "regulation_number": "",
      "implant_flag": "Y",
      "submission_type_id": "6"
    }
  ]
}