{
  "format": "devicerts.device.v1",
  "cite_as": "xvision Spine System, Augmedics Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/xvision-spine-system-sbf (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/xvision-spine-system-sbf",
    "json_url": "https://devicerts.com/devices/xvision-spine-system-sbf.json",
    "markdown_url": "https://devicerts.com/devices/xvision-spine-system-sbf.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/xvision-spine-system-sbf",
    "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": "xvision Spine System",
    "registry_name": "xvision Spine System",
    "url": "https://devicerts.com/devices/xvision-spine-system-sbf",
    "manufacturer": {
      "name": "Augmedics Ltd",
      "url": "https://devicerts.com/manufacturers/fda-fei-3016566146",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "Israel"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K241481",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "SBF"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The xvision Spine System is an Orthopedic Augmented Reality device designed to enhance surgical visualization during spine procedures. It integrates augmented reality technology to overlay anatomical structures, enabling surgeons to navigate instruments and implants with greater precision and accuracy. By providing real-time, three-dimensional imaging, it supports complex interventions such as spinal fusion, decompression, and instrumentation placement.\n\nThis system is intended for use in operating rooms during spine surgeries and is supplied as a reusable, non-sterile device. It requires calibration and integration with compatible surgical tools and imaging systems. The xvision Spine System is classified under FDA device class II (SBF) and holds a Traditional 510(k) clearance with the advisory committee designation for Neurology. It is regulated under FDA regulation number 882.4560 and is not intended for MRI use.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "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": "K241481",
      "number_label": null,
      "device_udi_di": null,
      "date": "2024-10-16",
      "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": "K241481",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "SBF",
              "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 882.4560",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Neurology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}