{
  "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": 36
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Rockville",
      "advisory_committee_description": "Orthopedic",
      "address_1": "12300 Twinbrook Pkwy., Suite 625",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "JDW",
      "openfda": {
        "registration_number": [
          "",
          "3016496998",
          "3007125392",
          "3008534770",
          "3006801265",
          "1220246",
          "1720747",
          "2249615",
          "3017406274",
          "1221934",
          "3015440604",
          "3010178296",
          "3010470577",
          "3013680140",
          "8043862",
          "3011137372",
          "3006694268",
          "3003108161",
          "1060840",
          "3009732568",
          "3025141",
          "2648623",
          "1828288",
          "3009888740",
          "1020279",
          "2936485",
          "3007993775",
          "3010041499",
          "3018269629",
          "3009973505",
          "3004976965",
          "1043534",
          "1018470",
          "8010916",
          "2134947",
          "3019356409",
          "1818910",
          "3009417901",
          "3007051929",
          "1825034",
          "3005061536",
          "2245304",
          "3014302784",
          "3001239363",
          "2919128",
          "3034676720",
          "3009973699",
          "3004983210",
          "3002907620",
          "3013011598",
          "3015207155",
          "3015216945",
          "3006513362",
          "1528668",
          "2244478",
          "3013540005",
          "3013055499",
          "3006460162",
          "3008110533",
          "3010041430",
          "3015709929",
          "3009756327",
          "3008559295",
          "1833986",
          "3014315669",
          "8031020",
          "3004176895",
          "3031240334",
          "3007887127",
          "3011656326",
          "3002807315",
          "3006395932",
          "3011301313",
          "3006017180",
          "1000517406",
          "3006783837",
          "3010123172",
          "3004889950",
          "1421101",
          "3015869121",
          "3025603301",
          "3003249380",
          "3033509898",
          "8010468",
          "3010673850",
          "3006946279",
          "2183946",
          "3008114965",
          "3010041511",
          "3007353762",
          "3003639920",
          "1835251",
          "1424263",
          "1043653",
          "2025102",
          "3036756245",
          "3005809810",
          "1526534",
          "3010407203",
          "3014129047",
          "3011500362",
          "3004369035",
          "1833506",
          "3004748528",
          "3011295718",
          "1828464",
          "8043792",
          "1225838",
          "9611863",
          "1423662",
          "2431166",
          "3008868758",
          "3013176080",
          "8043872",
          "3009882462",
          "9611274",
          "3010331645",
          "3030966822",
          "1643264",
          "1057425",
          "3023852420",
          "1051526",
          "9680619",
          "3015212339",
          "3035366890",
          "1833920",
          "3008951116",
          "1526439",
          "3004215117",
          "3003418325",
          "3015399803",
          "3015946784",
          "3005180920",
          "3010667733",
          "3015895045",
          "1226544",
          "1720929",
          "1220477",
          "3000270450",
          "3010220595",
          "1822565",
          "9615765",
          "3016438694",
          "1424434",
          "3008812560",
          "3021008900",
          "9680825",
          "3004464325",
          "2249529",
          "3006849754",
          "1835831",
          "3005641619",
          "3004358587",
          "3009116370",
          "3010536692",
          "3011277306",
          "3007366790",
          "2029275",
          "3038503932",
          "3011302692",
          "3008744062",
          "3014522470",
          "1226074",
          "1450662",
          "3015231789",
          "3005562917",
          "3042903229",
          "1835572",
          "1219930",
          "3004893332",
          "3033536312",
          "3007923096",
          "3004513872",
          "2183449",
          "3014315560",
          "3012770122",
          "3008812251",
          "3007130914",
          "2031910"
        ],
        "fei_number": [
          "",
          "3016496998",
          "3007125392",
          "3008534770",
          "3006801265",
          "3009322142",
          "1220246",
          "1720747",
          "3017406274",
          "1000220733",
          "1221934",
          "1000136269",
          "3015440604",
          "1832656",
          "1000125930",
          "3010470577",
          "3013680140",
          "3006694268",
          "2523865",
          "3003108161",
          "3009732568",
          "2648623",
          "1828288",
          "3009888740",
          "1020279",
          "2936485",
          "3007993775",
          "3018269629",
          "1000221916",
          "3009973505",
          "3004976965",
          "1043534",
          "3001049282",
          "3002808043",
          "1018470",
          "3000215273",
          "3019356409",
          "1818910",
          "3009417901",
          "3007051929",
          "1825034",
          "3002786339",
          "3003128516",
          "3007282753",
          "3005061536",
          "3001026312",
          "2245304",
          "3014302784",
          "3001239363",
          "3008647423",
          "2919128",
          "3034676720",
          "3002807830",
          "3009973699",
          "3002616700",
          "3004983210",
          "3002907620",
          "3002806577",
          "3002807038",
          "3013011598",
          "3015207155",
          "3015216945",
          "3006513362",
          "3006460162",
          "3013055499",
          "3013540005",
          "3004949275",
          "3008110533",
          "3010041430",
          "3015709929",
          "3002926812",
          "3008559295",
          "3014315669",
          "3002795782",
          "3004176895",
          "1000116116",
          "3002808269",
          "3031240334",
          "3007887127",
          "3011656326",
          "3002807315",
          "3001452082",
          "3006395932",
          "3011301313",
          "1000136409",
          "3006017180",
          "1000517406",
          "3010123172",
          "3004889950",
          "1421101",
          "3015869121",
          "3025603301",
          "3003249380",
          "3033509898",
          "3010673850",
          "3006946279",
          "3007353762",
          "3008114965",
          "3010041511",
          "3003639920",
          "1043653",
          "3001644153",
          "3036756245",
          "3005809810",
          "1526534",
          "3010407203",
          "3003569173",
          "3011500362",
          "3003756816",
          "3004369035",
          "3019827409",
          "3011295718",
          "3004748528",
          "1828464",
          "3000205819",
          "3008868758",
          "3013176080",
          "3009882462",
          "1000306431",
          "3003015552",
          "3010331645",
          "3030966822",
          "1643264",
          "3023852420",
          "1051526",
          "3015212339",
          "3035366890",
          "3008951116",
          "1526439",
          "3004215117",
          "3002807827",
          "3003418325",
          "3015399803",
          "3015946784",
          "3005180920",
          "3010667733",
          "3015895045",
          "1720929",
          "1220477",
          "3003110073",
          "3000205591",
          "3002807648",
          "3000270450",
          "3010220595",
          "3016438694",
          "3008812560",
          "1000139987",
          "3021008900",
          "3004464325",
          "3006849754",
          "3005641619",
          "1000115656",
          "3004358587",
          "3009116370",
          "3010536692",
          "3011277306",
          "3005747797",
          "3038503932",
          "3011302692",
          "3008744062",
          "3002807219",
          "3014522470",
          "3010938185",
          "1450662",
          "3015231789",
          "3005562917",
          "3042903229",
          "3001814066",
          "3001406084",
          "1219930",
          "3033536312",
          "3004893332",
          "3007923096",
          "3004513872",
          "2183449",
          "3014315560",
          "3012770122",
          "3007130914",
          "3002808293"
        ],
        "device_name": "Pin, Fixation, Threaded",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3040",
        "device_class": "2"
      },
      "zip_code": "20852",
      "applicant": "Orthofix Srl",
      "decision_date": "1998-03-18",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING",
      "advisory_committee": "OR",
      "contact": "ROBERT L SHERIDAN",
      "expedited_review_flag": "",
      "k_number": "K974186",
      "state": "MD",
      "date_received": "1997-11-07",
      "review_advisory_committee": "OR",
      "postal_code": "20852",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}