{
  "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",
      "public_device_record_key": "edd69c47-30ce-4d25-8a47-7093ced12508",
      "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": "1",
      "labeler_duns_number": "751993028",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "09348215058395",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "111-44-0103",
      "has_manufacturing_date": "true",
      "brand_name": "Spartan Hip Stem",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "MEH",
          "name": "Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate",
          "openfda": {
            "device_name": "Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3353",
            "device_class": "2"
          }
        },
        {
          "code": "LPH",
          "name": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented",
          "openfda": {
            "device_name": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3358",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K192883",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "company_name": "SIGNATURE ORTHOPAEDICS PTY LTD",
      "public_version_status": "New",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "33581",
          "name": "Coated hip femur prosthesis, modular",
          "definition": "A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.",
          "implantable": "true",
          "code_status": "Active"
        }
      ],
      "publish_date": "2020-09-01"
    }
  ]
}