{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "true",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "cup cementless",
      "public_device_record_key": "7d3649b3-aa0c-43b1-ad00-6ef9730b60d5",
      "has_serial_number": "false",
      "public_version_date": "2026-05-14",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "true",
        "sterilization_methods": "Radiation Sterilization"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "324369826",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "04048844711658",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "0220804400",
      "has_manufacturing_date": "false",
      "brand_name": "EPORE® XO",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "OQI",
          "name": "Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented",
          "openfda": {
            "device_name": "Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3353",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "company_name": "implantcast GmbH",
      "public_version_status": "New",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "43167",
          "name": "Acetabular shell",
          "definition": "An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.",
          "implantable": "true",
          "code_status": "Active"
        }
      ],
      "publish_date": "2026-05-06",
      "device_sizes": [
        {
          "type": "Device Size Text, specify",
          "text": "Ø 44 mm / sz. A"
        }
      ]
    }
  ]
}