{
  "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": "2026-04-13",
    "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": "PQC",
      "openfda": {
        "k_number": [
          "K253472",
          "K200792",
          "K203673",
          "K173472",
          "K181399",
          "K181883",
          "K231483",
          "K162419"
        ],
        "registration_number": [
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          "9681465",
          "3006017180",
          "8043792",
          "3008110533",
          "3005180920"
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      },
      "review_panel": "OR",
      "medical_specialty": "OR",
      "device_name": "Pedicle Screw Placement Guide",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Orthopedic",
      "device_class": "2",
      "definition": "A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.",
      "regulation_number": "888.3070",
      "implant_flag": "N",
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    }
  ]
}