{
  "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": "SMF STEM FIXED NECK SIZE 1 HIGH OFFSET",
      "public_device_record_key": "e2126293-ba2c-4ceb-be8d-fc34b0eabc05",
      "has_serial_number": "false",
      "public_version_date": "2023-09-07",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "7",
      "labeler_duns_number": "045483575",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00885556159149",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "71352701",
      "has_manufacturing_date": "false",
      "brand_name": "SMF",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "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": "K123012",
          "supplement_number": "000"
        },
        {
          "submission_number": "K211176",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+1(800)238-7538",
          "email": "GUDID@SMITH-NEPHEW.COM"
        }
      ],
      "catalog_number": "71352701",
      "company_name": "Smith & Nephew, Inc.",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "34191",
          "name": "Coated femoral stem prosthesis, modular",
          "definition": "A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. 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": "2015-08-30"
    }
  ]
}