{
  "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": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Morgan Hill",
      "advisory_committee_description": "Orthopedic",
      "address_1": "18655 Madrone Pkwy., Suite 180",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "SGL",
      "openfda": {
        "device_name": "Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.4520",
        "device_class": "2",
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      "applicant": "Empirical Spine",
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      "country_code": "US",
      "device_name": "LimiFlex® Dynamic Sagittal Tether Instrument Set",
      "advisory_committee": "OR",
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      "k_number": "K253374",
      "state": "CA",
      "date_received": "2025-09-30",
      "review_advisory_committee": "OR",
      "postal_code": "95037",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}