{
  "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": "Pleasant Hill",
      "advisory_committee_description": "Orthopedic",
      "address_1": "200 Gregory Ln. Suite C-100",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "KWI",
      "openfda": {
        "registration_number": [
          "",
          "2027487",
          "2133928",
          "3010863450",
          "3003477135",
          "3008421730",
          "1834331",
          "1649833",
          "3010178296",
          "2028632",
          "1649518",
          "1649379",
          "1030489",
          "3009826895",
          "3004635447",
          "3019767615",
          "3025141",
          "2032098",
          "3010120135",
          "1834379",
          "1020279",
          "3007993775",
          "3000931034",
          "1222928",
          "1043534",
          "2134947",
          "3010120148",
          "1818910",
          "3009417901",
          "1825034",
          "1824199",
          "3005061536",
          "3014302784",
          "3006742481",
          "2134285",
          "1226425",
          "2249697",
          "3034676720",
          "3009241418",
          "3002907620",
          "3020703621",
          "3015207155",
          "9611390",
          "3011580264",
          "3010041430",
          "8031020",
          "3014207283",
          "3010173425",
          "3008337808",
          "3006128100",
          "3006783837",
          "3043543260",
          "3004889950",
          "3033509898",
          "3025603301",
          "1058084",
          "3002807295",
          "2183946",
          "3010120104",
          "1424263",
          "1043653",
          "3036756245",
          "1526534",
          "3003761012",
          "1319429",
          "3004188066",
          "3004748528",
          "1522875",
          "1828464",
          "3006356043",
          "3002807310",
          "1423662",
          "3008868758",
          "3013176080",
          "3009959868",
          "3006846753",
          "3010386387",
          "3018094310",
          "3035366890",
          "3015399803",
          "3010667733",
          "3010032903",
          "1226544",
          "1720929",
          "3010049501",
          "3004142400",
          "1822565",
          "3008812560",
          "3021008900",
          "3004464325",
          "3005641619",
          "8010379",
          "3007366790",
          "2029275",
          "3038503932",
          "3008744062",
          "1450662",
          "3015516266",
          "3008108789",
          "1835572",
          "9610726"
        ],
        "fei_number": [
          "",
          "2027487",
          "3009322142",
          "3010863450",
          "3003477135",
          "3008421730",
          "1000220733",
          "1000125930",
          "3009826895",
          "3004635447",
          "3019767615",
          "3010120135",
          "3000717902",
          "1020279",
          "3007993775",
          "1000120613",
          "3000931034",
          "1043534",
          "3010120148",
          "3000215273",
          "1818910",
          "3009417901",
          "3002788818",
          "1825034",
          "3003128516",
          "1824199",
          "3003018882",
          "3005061536",
          "3007282753",
          "3014302784",
          "3006742481",
          "3003070421",
          "1000125025",
          "3034676720",
          "3009241418",
          "3002807830",
          "3002907620",
          "1000221981",
          "3020703621",
          "3002806773",
          "3015207155",
          "3011580264",
          "3010041430",
          "3002287318",
          "3000718490",
          "1000306303",
          "1000116116",
          "3008337808",
          "3001452082",
          "3006128100",
          "1000477302",
          "3043543260",
          "3004889950",
          "3002807172",
          "3033509898",
          "3025603301",
          "3002807295",
          "3010120104",
          "1043653",
          "3036756245",
          "1526534",
          "3003761012",
          "3004188066",
          "3004748528",
          "1522875",
          "3002807036",
          "1828464",
          "3006356043",
          "3002807310",
          "3008868758",
          "3013176080",
          "3009959868",
          "3001236277",
          "1000306431",
          "3003015552",
          "3006846753",
          "3010386387",
          "3018094310",
          "3035366890",
          "3001584317",
          "3015399803",
          "3010667733",
          "3010032903",
          "1720929",
          "3003110073",
          "3010049501",
          "3004142400",
          "3008812560",
          "3021008900",
          "3004464325",
          "1000199976",
          "3005641619",
          "1000306340",
          "3038503932",
          "3008744062",
          "3010938185",
          "1450662",
          "3015516266",
          "3008108789",
          "3003058448",
          "1000120314"
        ],
        "device_name": "Prosthesis, Elbow, Hemi-, Radial, Polymer",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3170",
        "device_class": "2"
      },
      "zip_code": "94523",
      "applicant": "Tornier, Inc.",
      "decision_date": "2000-08-31",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "TORNIER BIPOLAR RADIAL HEAD PROSTHESIS",
      "advisory_committee": "OR",
      "contact": "DAVID W SCHLERF",
      "expedited_review_flag": "",
      "k_number": "K994041",
      "state": "CA",
      "date_received": "1999-11-29",
      "review_advisory_committee": "OR",
      "postal_code": "94523",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}