{
  "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",
      "public_device_record_key": "8b62627a-ff9d-4f75-b138-730982bb84bd",
      "has_serial_number": "false",
      "public_version_date": "2025-05-30",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "2",
      "labeler_duns_number": "129278169",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00887868347849",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "CP0001913",
      "has_manufacturing_date": "false",
      "brand_name": "Miller Galante II",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "JWH",
          "name": "PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER",
          "openfda": {
            "device_name": "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3560",
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        {
          "submission_number": "K892800",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+1(800)348-9500",
          "email": "customerservice@zimmerbiomet.com"
        }
      ],
      "catalog_number": "CP0001913",
      "company_name": "Biomet Orthopedics, LLC",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "46585",
          "name": "Tibial insert",
          "definition": "An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.",
          "implantable": "true",
          "code_status": "Active"
        }
      ],
      "publish_date": "2020-01-17",
      "device_sizes": [
        {
          "type": "Device Size Text, specify",
          "text": "13mm Thickness"
        }
      ]
    }
  ]
}