{
  "format": "devicerts.device.v1",
  "cite_as": "Arvis ® In-28000, Kico Knee Innovation Company Pty Limited. deviCERTS medical device catalogue. https://devicerts.com/devices/arvis-r-in-28000 (data as of 2026-11-15).",
  "source": {
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    "markdown_url": "https://devicerts.com/devices/arvis-r-in-28000.md",
    "publisher": "deviCERTS (devicerts.com)",
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      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
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        "url": "https://ec.europa.eu/tools/eudamed"
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    "registry_records_last_synced": "2026-11-07",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/arvis-r-in-28000",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Arvis ® In-28000",
    "registry_name": "ARVIS ® IN-28000",
    "url": "https://devicerts.com/devices/arvis-r-in-28000",
    "manufacturer": {
      "name": "Kico Knee Innovation Company Pty Limited",
      "url": "https://devicerts.com/manufacturers/kico-knee-innovation-company-pty-limited",
      "country": "Australia",
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      "fda_registration_country": null
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    "status": {
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        "system": "EU MDR"
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      {
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          {
            "value": "00810180351805",
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      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "0888912000000S0104010A1RE",
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    "emdn": [
      {
        "code": "S010401",
        "term": "TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS"
      }
    ],
    "gmdn": [
      {
        "code": "13180",
        "term": "Orthopaedic prosthesis implantation positioning instrument, reusable"
      }
    ],
    "description": null,
    "noindex": false
  },
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    }
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      "number": "Z-2957-2026",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2026-07-13",
      "reason": "Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing",
      "applies": "this device",
      "via": "K243980"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
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          "label": "Device name",
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            {
              "value": "The ARVIS system is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated.",
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      "group": "Clinical & Handling",
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          "label": "Sterilisation method",
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            {
              "value": "Moist Heat or Steam Sterilization",
              "registries": [
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          "label": "Sterilise before use",
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          "label": "Convenience kit",
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          "label": "Manufacturing date",
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}