{
  "format": "devicerts.device.v1",
  "cite_as": "Fraxis, Ilooda.co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/fraxis-gex (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/fraxis-gex",
    "json_url": "https://devicerts.com/devices/fraxis-gex.json",
    "markdown_url": "https://devicerts.com/devices/fraxis-gex.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-14",
    "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/fraxis-gex",
    "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": "Fraxis",
    "registry_name": "Fraxis",
    "url": "https://devicerts.com/devices/fraxis-gex",
    "manufacturer": {
      "name": "Ilooda.co., Ltd",
      "url": "https://devicerts.com/manufacturers/ilooda-co-ltd",
      "country": "South Korea",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K172096",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "GEX"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "Fraxis is a Suture Anchor (Product Code: GEX) designed for use in orthopaedic and plastic surgery procedures. These devices are intended to secure soft tissue to bone, providing stable fixation for tendons, ligaments, or other anatomical structures during reconstructive or repair surgeries.\n\nThe device is supplied as a sterile, single-use product and is intended for use in surgical settings. It is classified under the FDA’s Special 510(k) pathway with a clearance type designated as Substantially Equivalent (SESE). No MRI safety classification or reusable specifications are noted in the regulatory submission.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K172096",
      "number_label": null,
      "device_udi_di": null,
      "date": "2017-08-09",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K172096",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "GEX",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 878.4810",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "General, Plastic Surgery",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}