{
  "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,
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Carlsbad",
      "advisory_committee_description": "Orthopedic",
      "address_1": "1950 Camino Vida Roble",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "SIN",
      "openfda": {
        "device_name": "Automated Intraoperative Spinal Rod Bending System",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3070",
        "device_class": "2"
      },
      "zip_code": "92008",
      "applicant": "Alphatec Spine, Inc.",
      "decision_date": "2026-06-25",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "IntraOp Alignment System; CONTOUR3D Bending System",
      "advisory_committee": "OR",
      "contact": "Unnati  Bhuptani",
      "expedited_review_flag": "",
      "k_number": "K253216",
      "state": "CA",
      "date_received": "2025-09-29",
      "review_advisory_committee": "RA",
      "postal_code": "92008",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
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}