{
  "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,
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    }
  },
  "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": "EMPERION 15 STEM SH REV POL +0",
      "public_device_record_key": "bc6eb597-89c5-47a2-b75d-919abf494a3c",
      "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": "5",
      "labeler_duns_number": "045483575",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "03596010536969",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "71291550",
      "has_manufacturing_date": "false",
      "brand_name": "EMPERION",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "MEH",
          "name": "Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-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"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K042127",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+1(800)821-5700",
          "email": "gudid@smith-nephew.com"
        }
      ],
      "catalog_number": "71291550",
      "company_name": "Smith & Nephew, Inc.",
      "public_version_status": "Update",
      "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": "2015-08-29"
    }
  ]
}