{
  "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": "Durham",
      "advisory_committee_description": "Orthopedic",
      "address_1": "4001 E. Nc 54 Hwy., Suite 3160",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "HSN",
      "openfda": {
        "registration_number": [
          "1000200989",
          "2133928",
          "3003477135",
          "3008421730",
          "2249615",
          "1221934",
          "1834331",
          "2183744",
          "3010178296",
          "3010470577",
          "1649518",
          "3008658204",
          "3010162973",
          "3009826895",
          "3004635447",
          "3011015572",
          "2090040",
          "3009888740",
          "3015526568",
          "1043534",
          "2027062",
          "3014833750",
          "1018470",
          "3005596372",
          "1818910",
          "3008650117",
          "3010141347",
          "2134285",
          "3010462278",
          "3010047402",
          "3020703621",
          "2528981",
          "3010123256",
          "3009973336",
          "3010009693",
          "3014207283",
          "3016084569",
          "3012275107",
          "3006128100",
          "1038671",
          "3004889950",
          "3033509898",
          "3025603301",
          "3009923578",
          "3004153896",
          "3007353762",
          "1424263",
          "1835251",
          "1043653",
          "3036756245",
          "3012494775",
          "1526534",
          "3009971621",
          "1721676",
          "2246552",
          "3009887475",
          "1225838",
          "1423662",
          "3008868758",
          "3007922509",
          "3009882462",
          "3006272282",
          "1057425",
          "1051526",
          "3010375065",
          "3006791286",
          "3007648354",
          "3013014058",
          "1531174",
          "3027071765",
          "3010667733",
          "1226544",
          "1720929",
          "3007740680",
          "3010057495",
          "3012234585",
          "1220477",
          "1822565",
          "1424434",
          "1834179",
          "3006217744",
          "3014680149",
          "3011277306",
          "1724955",
          "9611579",
          "1450662",
          "3010039400",
          "3005144609",
          "3020745236",
          "1835572",
          "3004513872",
          "3011189525",
          "1221053"
        ],
        "fei_number": [
          "1000200989",
          "3003477135",
          "3002807041",
          "3008421730",
          "1000220733",
          "1221934",
          "2183744",
          "3010470577",
          "3008658204",
          "3009826895",
          "3004635447",
          "3011015572",
          "3003142829",
          "3009888740",
          "3000717902",
          "3015526568",
          "1000221916",
          "1043534",
          "2027062",
          "3014833750",
          "3001049282",
          "3002904345",
          "1018470",
          "3005596372",
          "3000215273",
          "1818910",
          "3008650117",
          "3002788818",
          "3003128516",
          "3010141347",
          "3010462278",
          "3010047402",
          "3020703621",
          "1000160371",
          "2528981",
          "3002287318",
          "3010123256",
          "3009973336",
          "3010009693",
          "3002795782",
          "3002993297",
          "3016084569",
          "3012275107",
          "3001452082",
          "3006128100",
          "1038671",
          "3004889950",
          "3033509898",
          "3025603301",
          "3009923578",
          "3004153896",
          "3007353762",
          "1043653",
          "3001644153",
          "3036756245",
          "3012494775",
          "1526534",
          "3009971621",
          "1721676",
          "2246552",
          "3009887475",
          "3008868758",
          "3007922509",
          "3001236277",
          "3009882462",
          "3003015552",
          "3006272282",
          "1051526",
          "3010375065",
          "3006791286",
          "3007648354",
          "3013014058",
          "3027071765",
          "3010667733",
          "1720929",
          "3007740680",
          "3010057495",
          "3012234585",
          "3003110073",
          "3000205591",
          "1220477",
          "3006217744",
          "3014680149",
          "3011277306",
          "1000306340",
          "3002615969",
          "1450662",
          "3010039400",
          "3005144609",
          "3020745236",
          "3004513872",
          "3011189525",
          "1221053"
        ],
        "device_name": "Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3110",
        "device_class": "2"
      },
      "zip_code": "27709",
      "applicant": "Restor3D",
      "decision_date": "2023-11-28",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Kinos Axiom Total Ankle System",
      "advisory_committee": "OR",
      "contact": "Brianna  Prindle",
      "expedited_review_flag": "",
      "k_number": "K232595",
      "state": "NC",
      "date_received": "2023-08-25",
      "review_advisory_committee": "OR",
      "postal_code": "27709",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}