{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QVI",
      "openfda": {
        "k_number": [
          "K223075",
          "K233223"
        ],
        "registration_number": [
          "1220477",
          "3013378907",
          "3017505709"
        ],
        "fei_number": [
          "1220477",
          "3013378907",
          "3017505709"
        ]
      },
      "review_panel": "OR",
      "medical_specialty": "OR",
      "device_name": "Screw Sleeve Bone Fixation Device, Spine",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Orthopedic",
      "device_class": "2",
      "definition": "A spinal screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.",
      "regulation_number": "888.3043",
      "implant_flag": "Y",
      "submission_type_id": "1"
    }
  ]
}