{
  "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",
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      "has_donation_id_number": "false",
      "mri_safety": "MR Conditional",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "true",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Modular Bi-Polar  46mm Dia.  (28mm Head) For Uncemented Applications",
      "public_device_record_key": "90de4ce3-fb48-49e9-a245-93b9ed634253",
      "has_serial_number": "false",
      "storage": [
        {
          "type": "Special Storage Condition, Specify",
          "special_conditions": "Room temperature and Dry"
        }
      ],
      "public_version_date": "2024-04-08",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "true",
      "public_version_number": "4",
      "labeler_duns_number": "346627222",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
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          "id": "05051693307629",
          "type": "Primary",
          "issuing_agency": "GS1"
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      ],
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      "is_otc": "false",
      "version_or_model_number": "Modular Bi-Polar (46mm- 28mm Head)",
      "has_manufacturing_date": "true",
      "brand_name": "RING-LOK",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "KWY",
          "name": "Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented",
          "openfda": {
            "device_name": "Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented",
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            "device_class": "2"
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          "submission_number": "K132539",
          "supplement_number": "000"
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      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+4401642769080",
          "email": "michael.russon@implantsinternational.com"
        },
        {
          "phone": "+4401642769080",
          "email": "mohan.emmanuel@implantsinternational.com"
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      "company_name": "IMPLANTS INTERNATIONAL LTD",
      "public_version_status": "Update",
      "has_expiration_date": "true",
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      "gmdn_terms": [
        {
          "code": "33175",
          "name": "Metallic femoral head prosthesis",
          "definition": "An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.",
          "implantable": "true",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-07-31",
      "device_sizes": [
        {
          "type": "Outer Diameter",
          "value": "46",
          "unit": "Millimeter"
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      ]
    }
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}