{
  "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": "Cork",
      "advisory_committee_description": "Orthopedic",
      "address_1": "Loughbeg Ringaskiddy",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MBH",
      "openfda": {
        "registration_number": [
          "",
          "3017397663",
          "3004986960",
          "1219602",
          "3006801265",
          "3002806470",
          "1221763",
          "1000200989",
          "1220246",
          "3005852519",
          "3042172882",
          "2133928",
          "3003477135",
          "3015806723",
          "3003998208",
          "3009173317",
          "3010287737",
          "3005279746",
          "3007516837",
          "1834331",
          "2249615",
          "1644408",
          "3005360851",
          "2183744",
          "3012491394",
          "3008544874",
          "1649518",
          "9681465",
          "3008572101",
          "3008658204",
          "3006694268",
          "3009732568",
          "3011015572",
          "3004153240",
          "1828288",
          "3009888740",
          "1020279",
          "3009848551",
          "3009973505",
          "3004976965",
          "3009555447",
          "3014833750",
          "3004371426",
          "3010041693",
          "1018470",
          "3005596372",
          "2242737",
          "1061927",
          "3010388970",
          "1319660",
          "1818910",
          "1825034",
          "9680215",
          "3008021110",
          "3009813841",
          "3005061536",
          "3009106092",
          "3011187779",
          "2245304",
          "3014302784",
          "3026771806",
          "3011461101",
          "3016851379",
          "9610612",
          "2134285",
          "2249697",
          "1047843",
          "1226188",
          "9617840",
          "3002579136",
          "3002907620",
          "3010047402",
          "3020703621",
          "3016090213",
          "3015207155",
          "3012392319",
          "3022142628",
          "2244478",
          "3013055499",
          "3008110533",
          "2528981",
          "3007913880",
          "3010856250",
          "1530390",
          "3010123256",
          "3009582259",
          "3013791180",
          "1833986",
          "3009973336",
          "3010009693",
          "3002807314",
          "3002806603",
          "3002993234",
          "3010173425",
          "3003387384",
          "3012130008",
          "1646498",
          "3008281151",
          "3006395932",
          "1038671",
          "1643817",
          "3011724582",
          "1645151",
          "3006017180",
          "1000517406",
          "1835444",
          "3019006180",
          "3004889950",
          "3025603301",
          "3009923578",
          "3000264985",
          "3033509898",
          "3007963827",
          "3005581234",
          "3004153896",
          "3013417938",
          "2183946",
          "3003639920",
          "1835251",
          "1424263",
          "3036773273",
          "1043653",
          "9616680",
          "3036756245",
          "1526534",
          "1721676",
          "2648920",
          "3009656988",
          "3007539489",
          "3008262872",
          "3030412764",
          "2246552",
          "3004748528",
          "3011295718",
          "1828464",
          "3009887475",
          "8043792",
          "3006356043",
          "3002807310",
          "3020155054",
          "1423662",
          "3009293341",
          "3013176080",
          "3008868758",
          "3009882462",
          "3004450489",
          "3009555440",
          "3016470314",
          "3007189546",
          "3010331645",
          "9613350",
          "3010155661",
          "1643264",
          "3010386387",
          "1057425",
          "1832228",
          "3023852420",
          "9613369",
          "2531477",
          "3010375065",
          "3006791286",
          "3035366890",
          "3006015326",
          "3013014058",
          "1531174",
          "1833920",
          "1722511",
          "3000236920",
          "3007311878",
          "3005180920",
          "1226544",
          "1720929",
          "3010057495",
          "9681642",
          "1220477",
          "3010220595",
          "3005751028",
          "3012725451",
          "3009760038",
          "1064858",
          "3004142400",
          "1822565",
          "3016438694",
          "3005718816",
          "3021008900",
          "9616671",
          "3012329926",
          "1827096",
          "2032093",
          "3009475821",
          "3010536692",
          "3011277306",
          "8010379",
          "3007366790",
          "3038503932",
          "3008744062",
          "3002808022",
          "3011061242",
          "1450662",
          "3015231789",
          "3005562917",
          "3010039400",
          "3017410889",
          "3005874553",
          "3005144609",
          "3015516266",
          "1054811",
          "1835572",
          "3007923096",
          "3012319330",
          "1529009",
          "3008812251",
          "9610726",
          "1219655",
          "3003541440",
          "3015916578",
          "3008395353",
          "3014763043"
        ],
        "fei_number": [
          "",
          "3017397663",
          "3004986960",
          "1219602",
          "3006801265",
          "3002806470",
          "1221763",
          "1000200989",
          "1220246",
          "3005852519",
          "3042172882",
          "3003477135",
          "3015806723",
          "3003998208",
          "3009173317",
          "3010287737",
          "3005279746",
          "3007516837",
          "1000136269",
          "1000220733",
          "3005360851",
          "1000136478",
          "2183744",
          "3001642380",
          "3012491394",
          "3008544874",
          "3008572101",
          "3008658204",
          "1000395711",
          "3006694268",
          "3009732568",
          "3011015572",
          "3004153240",
          "1828288",
          "3009888740",
          "3000717902",
          "1020279",
          "3009848551",
          "1000221916",
          "3009973505",
          "3004976965",
          "3001049282",
          "3009555447",
          "3014833750",
          "3010041693",
          "1000143502",
          "1018470",
          "3003386935",
          "3005596372",
          "3000215273",
          "3001548076",
          "3010388970",
          "1818910",
          "1825034",
          "3003128516",
          "3008021110",
          "3009813841",
          "3005061536",
          "3009106092",
          "3011187779",
          "2245304",
          "3014302784",
          "3008342029",
          "3026771806",
          "3011461101",
          "1000116912",
          "3016851379",
          "3003070421",
          "3007282753",
          "1047843",
          "3002806315",
          "3002807893",
          "3002579136",
          "3002907620",
          "3010047402",
          "3020703621",
          "3016090213",
          "3015207155",
          "3012392319",
          "3005985723",
          "3022142628",
          "3013055499",
          "3008110533",
          "2528981",
          "3007913880",
          "3010856250",
          "3002287318",
          "3010123256",
          "3008397795",
          "3009582259",
          "3013791180",
          "3000215103",
          "3009973336",
          "3010009693",
          "3002807314",
          "3002993297",
          "3002806603",
          "3002993234",
          "3003387384",
          "1000116116",
          "3002808269",
          "3012130008",
          "3008281151",
          "3001452082",
          "3006395932",
          "1038671",
          "1643817",
          "3011724582",
          "3006017180",
          "1000517406",
          "3019006180",
          "3004889950",
          "3005233524",
          "3002807172",
          "3025603301",
          "3009923578",
          "3000264985",
          "3033509898",
          "3002807113",
          "3007963827",
          "3005581234",
          "3004153896",
          "3013417938",
          "3003639920",
          "3036773273",
          "1043653",
          "3036756245",
          "1526534",
          "3003058119",
          "1721676",
          "1000132037",
          "3009656988",
          "3007539489",
          "3008262872",
          "3030412764",
          "2246552",
          "3004748528",
          "3011295718",
          "3002807036",
          "3009887475",
          "1828464",
          "3006356043",
          "3002807310",
          "3020155054",
          "3009293341",
          "3013176080",
          "3008868758",
          "1000149660",
          "3001236277",
          "3009882462",
          "3004450489",
          "3009555440",
          "3003714383",
          "3016470314",
          "3003015552",
          "3007189546",
          "3010331645",
          "3010155661",
          "1643264",
          "3010386387",
          "1832228",
          "3023852420",
          "3010375065",
          "3002854251",
          "3006791286",
          "3000203000",
          "3035366890",
          "3006015326",
          "3013014058",
          "3007311878",
          "3005180920",
          "1720929",
          "3010057495",
          "1220477",
          "3000205591",
          "3010220595",
          "3001084824",
          "3012725451",
          "3005751028",
          "3009760038",
          "3004142400",
          "3016438694",
          "3005718816",
          "1000139987",
          "3021008900",
          "1000199976",
          "3012329926",
          "1827096",
          "1000115656",
          "3000717687",
          "1000086912",
          "3009475821",
          "3010536692",
          "3011277306",
          "1000306340",
          "3038503932",
          "3008744062",
          "3002808022",
          "3011061242",
          "1450662",
          "3015231789",
          "3005562917",
          "3010039400",
          "3005874553",
          "3005144609",
          "3015516266",
          "3007923096",
          "3012319330",
          "1000114185",
          "1000118610",
          "3002459190",
          "3002808293",
          "1219655",
          "1000138247",
          "3003541440",
          "3015916578",
          "3008395353",
          "3014763043"
        ],
        "device_name": "Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3565",
        "device_class": "2"
      },
      "zip_code": "",
      "applicant": "Depuy Ireland UC",
      "decision_date": "2024-06-18",
      "decision_code": "SESE",
      "country_code": "IE",
      "device_name": "ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology",
      "advisory_committee": "OR",
      "contact": "Catherine  O Regan",
      "expedited_review_flag": "",
      "k_number": "K240678",
      "state": "",
      "date_received": "2024-03-11",
      "review_advisory_committee": "OR",
      "postal_code": "",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}