{
  "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": "Femoral Head Ø 28 Size L",
      "public_device_record_key": "108e95c3-032d-4aed-9d88-97e1d091c0a2",
      "has_serial_number": "false",
      "public_version_date": "2020-09-09",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "4",
      "labeler_duns_number": "488227125",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "07630030809149",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "01.29.203",
      "has_manufacturing_date": "false",
      "brand_name": "Mectacer Biolox Delta Femoral Ball Head",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "LZO",
          "name": "Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented",
          "openfda": {
            "device_name": "Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3353",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K112115",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "company_name": "Medacta International SA",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "38156",
          "name": "Ceramic femoral head prosthesis",
          "definition": "An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.",
          "implantable": "true",
          "code_status": "Active"
        }
      ],
      "publish_date": "2014-11-18"
    }
  ]
}