{
  "format": "devicerts.device.v1",
  "cite_as": "Medart 620, Medart A/S. deviCERTS medical device catalogue. https://devicerts.com/devices/medart-620-gex (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/medart-620-gex",
    "json_url": "https://devicerts.com/devices/medart-620-gex.json",
    "markdown_url": "https://devicerts.com/devices/medart-620-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": "2026-11-15",
    "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/medart-620-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": "Medart 620",
    "registry_name": "MEDART 620",
    "url": "https://devicerts.com/devices/medart-620-gex",
    "manufacturer": {
      "name": "Medart A/S",
      "url": "https://devicerts.com/manufacturers/medart-a-s",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "United States"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
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        "values": [
          {
            "value": "K120573",
            "registries": [
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          }
        ]
      }
    ],
    "product_codes": [
      "GEX"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Medart 620 is a suture anchor designed for use in orthopaedic and plastic surgery procedures. It provides secure fixation of soft tissue or tendon to bone, utilising a self-drilling and self-tapping mechanism to minimise trauma during implantation.\n\nThis device is supplied as a sterile, single-use product and is intended for use in surgical settings. It is classified under product code GEX and has received FDA 510(k) clearance as substantially equivalent under the Special 510(k) Review Program. Storage and handling must comply with standard surgical instrument protocols to maintain sterility and functionality.",
      "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": "K120573",
      "number_label": null,
      "device_udi_di": null,
      "date": "2012-06-13",
      "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",
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            {
              "value": "K120573",
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                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
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            {
              "value": "GEX",
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 878.4810",
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          ]
        },
        {
          "label": "Advisory committee",
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            {
              "value": "General, Plastic Surgery",
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            }
          ]
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}