{
  "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": "b6db9f55-6003-4fdb-b46c-0b4d54943995",
      "has_serial_number": "false",
      "public_version_date": "2025-10-20",
      "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": "09348215137861",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "111-55-1010",
      "has_manufacturing_date": "true",
      "brand_name": "Longboard Revision Stem Monobloc Ø10 LO 190mm",
      "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"
          }
        },
        {
          "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"
          }
        },
        {
          "code": "KWZ",
          "name": "Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer",
          "openfda": {
            "device_name": "Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3310",
            "device_class": "2"
          }
        },
        {
          "code": "KWL",
          "name": "Prosthesis, Hip, Hemi-, Femoral, Metal",
          "openfda": {
            "device_name": "Prosthesis, Hip, Hemi-, Femoral, Metal",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3360",
            "device_class": "2"
          }
        },
        {
          "code": "KWY",
          "name": "Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented",
          "openfda": {
            "device_name": "Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3390",
            "device_class": "2"
          }
        },
        {
          "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": "K243021",
          "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": "38155",
          "name": "Press-fit femoral stem prosthesis",
          "definition": "A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].",
          "implantable": "true",
          "code_status": "Active"
        }
      ],
      "publish_date": "2025-10-10"
    }
  ]
}