{
  "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": {
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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": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Collarless STD Size 1",
      "public_device_record_key": "01eb5a33-fb8f-466f-8ed0-cfd6b76d8840",
      "has_serial_number": "false",
      "public_version_date": "2025-09-30",
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        "is_sterilization_prior_use": "false"
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      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "876542390",
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      "identifiers": [
        {
          "id": "00822409123407",
          "type": "Primary",
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      ],
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      "is_otc": "false",
      "version_or_model_number": "513-0001",
      "has_manufacturing_date": "false",
      "brand_name": "Trivicta",
      "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",
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          "email": "customerservice@odev.com"
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      ],
      "company_name": "Ortho Development Corporation",
      "public_version_status": "New",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "55834",
          "name": "Press-fit hip femur prosthesis, one-piece",
          "definition": "A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is one-piece and 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 may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.",
          "implantable": "true",
          "code_status": "Active"
        }
      ],
      "publish_date": "2025-09-22"
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}