{
  "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",
      "city": "Audubon",
      "advisory_committee_description": "Orthopedic",
      "address_1": "2560 General Armistead Ave.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NQW",
      "openfda": {
        "registration_number": [
          "1226544",
          "3004499989",
          "1220477",
          "1000200989",
          "3000270450",
          "2183946",
          "3008114965",
          "3010863450",
          "3015869493",
          "1424263",
          "1835251",
          "3003477135",
          "3012131184",
          "3003120897",
          "3036756245",
          "1526534",
          "3015440604",
          "2647346",
          "3016438694",
          "3004142400",
          "3010041993",
          "1424434",
          "3008812560",
          "2530808",
          "3010047454",
          "3014725904",
          "3030412764",
          "3003761012",
          "3004188066",
          "3033509898",
          "1030489",
          "3005819474",
          "3010041430",
          "3021559833",
          "9611813",
          "3008868758",
          "3009959868",
          "3009144915",
          "3012120772",
          "3010120135",
          "2134470",
          "3010097171",
          "3005031160",
          "3007993775",
          "1224360",
          "3012447612",
          "3006846753",
          "3009973505",
          "3018094310",
          "2031966",
          "3010120148",
          "2183449",
          "3016050940",
          "3009417901",
          "1824199",
          "1833920",
          "3006783837",
          "1526439",
          "3019837678",
          "3004024955",
          "9617544",
          "3004889950",
          "3043543260",
          "3003935342",
          "3015399803",
          "3025603301",
          "9610612",
          "3010032903"
        ],
        "fei_number": [
          "3004499989",
          "1000514086",
          "1220477",
          "3009322142",
          "1000200989",
          "3000205591",
          "3000270450",
          "3008114965",
          "3010863450",
          "3015869493",
          "3003477135",
          "3003112432",
          "3012131184",
          "3003120897",
          "3036756245",
          "1526534",
          "3015440604",
          "2647346",
          "3016438694",
          "3004142400",
          "3010041993",
          "3008812560",
          "3010047454",
          "3014725904",
          "3030412764",
          "1000115656",
          "3003761012",
          "1000522098",
          "3004188066",
          "3033509898",
          "3005819474",
          "3002806685",
          "3010041430",
          "3002980729",
          "3021559833",
          "3008868758",
          "3009959868",
          "3009144915",
          "3012120772",
          "3010120135",
          "3005031160",
          "3010097171",
          "3002462840",
          "3002806315",
          "3007993775",
          "3003015552",
          "3002795782",
          "3012447612",
          "3006846753",
          "3009973505",
          "1000116116",
          "3018094310",
          "3010120148",
          "2183449",
          "3016050940",
          "3009417901",
          "3003128516",
          "1824199",
          "1000477302",
          "3004024955",
          "1526439",
          "3019837678",
          "3043543260",
          "3004889950",
          "3003935342",
          "3015399803",
          "3025603301",
          "3010032903"
        ],
        "device_name": "Orthosis, Spine, Plate, Laminoplasty, Metal",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3050",
        "device_class": "2"
      },
      "zip_code": "19403",
      "applicant": "Globus Medical, Inc.",
      "decision_date": "2017-07-14",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System",
      "advisory_committee": "OR",
      "contact": "Kelly J. Baker",
      "expedited_review_flag": "",
      "k_number": "K171413",
      "state": "PA",
      "date_received": "2017-05-15",
      "review_advisory_committee": "OR",
      "postal_code": "19403",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}