{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 31
    }
  },
  "results": [
    {
      "proprietary_name": [
        "ACS® FB trial PE insert SC 3/11,25mm",
        "ACS® FB trial PE insert hyperflex 5/13,75mm",
        "ACS® FB trial PE insert ultra 6/11,25mm",
        "ACS® FB trial PE insert hyperflex 3/12,5mm",
        "ACS® FB trial PE insert ultra 4/11,25mm",
        "ACS® FB trial PE insert ultra 5/13,75mm",
        "ACS® FB trial PE insert hyperflex 4/11,25mm",
        "Salto Talaris Total Ankle Prosthesis",
        "MK trial femoral spacer posterior 5/10mm",
        "ACS® FB tibial trial spacer ll/rm 3,5/5mm",
        "ACS® FB trial PE insert SC 5/10mm",
        "ACS® FB tibial trial spacer rl/lm 6/5mm",
        "ACS® FB trial PE insert PS 3/11,25mm",
        "MK trial femoral spacer distal ll/rm 2,5/5mm",
        "MK trial femoral spacer distal ll/rm 6/5mm",
        "MK trial femoral spacer distal ll/rm 3/5mm",
        "ACS® PE patella trial 32mm",
        "MK trial femoral spacer distal ll/rm 2/10mm",
        "ACS® FB trial PE insert PS 4/10mm",
        "ACS® FB tibial trial adapter 5 15mm",
        "MK trial femoral spacer distal ll/rm 4/10mm",
        "MK trial femoral spacer distal rl/lm 5/5mm",
        "ACS® FB trial PE insert PS 4/11,25mm",
        "AGILON® XO trial glenoid sz. 4",
        "ACS® FB trial PE insert PS 6/12,5mm",
        "ACS® FB trial PE insert 4/13,75mm",
        "ACS® FB trial PE insert PS 6/13,75mm",
        "ACS® FB tibial trial adapter 5 20mm",
        "MK trial femoral spacer posterior 5/5mm",
        "MK trial femoral spacer distal rl/lm 6/5mm",
        "MK trial femoral spacer posterior 2/5mm",
        "MK trial femoral spacer distal ll/rm 2,5/10mm",
        "ACS® FB tibial trial spacer rl/lm 2/10mm",
        "ACS® FB tibial trial adapter 2 20mm",
        "ACS® FB trial PE insert PS 4/13,75mm",
        "ACS® FB trial PE insert hyperflex 3/10mm",
        "ACS® FB tibial trial spacer rl/lm 4/5mm",
        "ACS® FB trial PE insert PS 6/10mm",
        "ACS® FB trial PE insert ultra 6 12,5mm",
        "MK trial femoral spacer posterior 2/10mm",
        "ACS® FB trial PE insert SC 2/10mm",
        "ACS® FB tibial trial adapter 5 17,5mm",
        "MK trial femoral spacer posterior 6/5mm",
        "ACS® FB trial PE insert PS 3/13,75mm",
        "ACS® FB tibial trial spacer ll/rm 6/10mm",
        "ACS® FB tibial trial adapter 3 17,5mm",
        "MK trial femoral spacer posterior 3/5mm",
        "MK trial femoral spacer distal ll/rm 5/10mm",
        "MK trial femoral spacer distal ll/rm 6/10mm",
        "ACS® FB trial PE insert 3/11,25mm",
        "ACS® FB trial PE insert hyperflex 5/10mm",
        "ACS® FB tibial trial adapter 2 15mm",
        "ACS® FB trial PE insert ultra 3 12,5mm",
        "ACS® FB tibial trial spacer rl/lm 5/5mm",
        "ACS® FB trial PE insert PS 5/11,25mm",
        "ACS® FB tibial trial adapter 4 15mm",
        "ACS® FB trial PE insert SC 6/12,5mm",
        "ACS® FB tibial trial spacer ll/rm 4/10mm",
        "ACS® FB trial PE insert SC 5/11,25mm",
        "MK trial femoral spacer distal rl/lm 6/10mm",
        "MK trial femoral spacer distal rl/lm 2,5/10mm",
        "ACS® FB trial PE insert ultra 5 10mm",
        "ACS® FB tibial trial spacer rl/lm 5/10mm",
        "ACS® FB tibial trial spacer rl/lm 2/5mm",
        "ACS® FB tibial trial spacer ll/rm 2,5/5mm",
        "MK trial femoral spacer posterior 6/10mm",
        "MK trial femoral spacer distal rl/lm 2/10mm",
        "ACS® FB tibial trial spacer ll/rm 3/10mm",
        "ACS® FB trial PE insert ultra 5 12,5mm",
        "ACS® FB tibial trial spacer rl/lm 3/5mm",
        "ACS® FB trial PE insert ultra 2/13,75mm",
        "ACS® FB trial PE insert ultra 3/13,75mm",
        "MK trial femoral spacer posterior 2,5/10mm",
        "ACS® FB trial PE insert ultra 3 10mm",
        "ACS® FB tibial trial spacer ll/rm 5/5mm",
        "ACS® FB trial PE insert 5/13,75mm",
        "ACS® FB trial PE insert SC 2/11,25mm",
        "MK trial femoral spacer distal rl/lm 4/5mm",
        "ACS® FB trial PE insert PS 6/11,25mm",
        "ACS® FB trial PE insert SC 3/12,5mm",
        "ACS® FB trial PE insert hyperflex 2/11,25mm",
        "ACS® FB trial PE insert PS 3/10mm",
        "ACS® FB tibial trial adapter 6 17,5mm",
        "MK trial femoral spacer posterior 3/10mm",
        "MK trial femoral spacer distal ll/rm 3/10mm",
        "MK trial femoral spacer posterior 4/10mm",
        "MK trial femoral spacer distal rl/lm 3/5mm",
        "ACS® FB tibial trial adapter 3 20mm",
        "ACS® FB trial PE insert SC 6/11,25mm",
        "ACS® FB trial PE-insert hyperflex 5/11,25mm",
        "ACS® FB trial PE insert hyperflex 6/13,75mm",
        "ACS® FB tibial trial spacer rl/lm 3,5/5mm",
        "MK trial femoral spacer posterior 2,5/5mm",
        "ACS® FB trial PE insert PS 4/12,5mm",
        "MK trial femoral spacer distal rl/lm 3/10mm",
        "ACS® PE patella trial 35mm",
        "ACS® FB tibial trial spacer ll/rm 4/5mm",
        "ACS® FB trial PE insert ultra 4 10mm",
        "ACS® FB trial PE insert SC 4/10mm",
        "ACS® FB trial PE insert hyperflex 6/11,25mm",
        "ACS® FB trial PE insert ultra 4/13,75mm",
        "ACS® FB trial PE insert ultra 2/11,25mm",
        "ACS® FB trial PE insert ultra 6/13,75mm",
        "MK trial femoral spacer distal ll/rm 4/5mm",
        "ACS® FB trial PE insert ultra 4 12,5mm",
        "ACS® FB trial PE insert PS 2/10mm",
        "ACS® FB trial PE insert hyperflex 6/10mm",
        "ACS® FB trial PE insert hyperflex 3/13,75mm",
        "ACS® FB trial PE insert SC 4/11,25mm",
        "ACS® FB trial PE insert hyperflex 2/13,75mm",
        "ACS® FB trial PE insert hyperflex 6/12,5mm",
        "ACS® FB trial PE insert SC 5/13,75mm",
        "MK trial femoral spacer distal rl/lm 4/10mm",
        "ACS® FB trial PE insert ultra 2/10mm",
        "ACS® FB trial PE insert PS 2/12,5mm",
        "Aequalis® Reversed Fracture",
        "ACS® FB tibial trial spacer ll/rm 2/10mm",
        "ACS® PE patella trial 29mm",
        "ACS® FB tibial trial adapter 6 20mm",
        "ACS® FB tibial trial spacer rl/lm 2,5/10mm",
        "ACS® FB trial PE insert hyperflex 4/10mm",
        "ACS® FB trial PE insert ultra 5/11,25mm",
        "ACS® FB tibial trial spacer rl/lm 2,5/5mm",
        "ACS® FB trial PE insert SC 5/12,5mm",
        "ACS® FB trial PE insert 2/13,75mm",
        "ACS® PE patella trial 26mm",
        "ACS® FB tibial trial spacer rl/lm 3,5/10mm",
        "AGILON® XO trial glenoid sz. 3",
        "ACS® FB tibial trial spacer rl/lm 4/10mm",
        "ACS® FB trial PE insert hyperflex 4/12,5mm",
        "ACS® FB trial PE insert 4/11,25mm",
        "ACS® FB tibial trial adapter 2 17,5mm",
        "ACS® FB tibial trial spacer ll/rm 5/10mm",
        "ACS® FB trial PE insert PS 2/11,25mm",
        "ACS® FB trial PE insert SC 3/10mm",
        "ACS® FB trial PE insert SC 6/13,75mm",
        "ACS® FB trial PE insert hyperflex 5/12,5mm",
        "ACS® FB trial PE insert PS 5/12,5mm",
        "ACS® FB trial PE insert 5/11,25mm",
        "ACS® FB trial PE insert 6/11,25mm",
        "ACS® FB trial PE insert 3/13,75mm",
        "MK trial femoral spacer distal rl/lm 2,5/5mm",
        "AGILON® XO trial glenoid sz. 1",
        "ACS® FB tibial trial spacer ll/rm 2/5mm",
        "ACS® FB tibial trial spacer ll/rm 2,5/10mm",
        "ACS® FB tibial trial adapter 3 15mm",
        "ACS® FB trial PE insert SC 6/10mm",
        "ACS® FB trial PE insert SC 2/12,5mm",
        "ACS® FB tibial trial adapter 4 17,5mm",
        "ACS® FB trial PE insert PS 2/13,75mm",
        "ACS® FB tibial trial spacer ll/rm 3/5mm",
        "ACS® FB trial PE insert 2/11,25mm",
        "AGILON® XO trial glenoid sz. 2",
        "ACS® FB trial PE insert PS 5/10mm",
        "MK trial femoral spacer distal ll/rm 5/5mm",
        "MK trial femoral spacer posterior 4/5mm",
        "ACS® FB tibial trial adapter 6 15mm",
        "MK trial femoral spacer distal rl/lm 5/10mm",
        "ACS® FB trial PE insert ultra 2 12,5mm",
        "ACS® FB tibial trial spacer rl/lm 6/10mm",
        "ACS® FB tibial trial adapter 4 20mm",
        "ACS® FB trial PE insert 6/13,75mm",
        "ACS® FB trial PE insert hyperflex 3/11,25mm",
        "ACS® FB trial PE insert SC 3/13,75mm",
        "MK trial femoral spacer distal ll/rm 2/5mm",
        "ACS® FB trial PE insert SC 4/12,5mm",
        "ACS® FB tibial trial spacer ll/rm 6/5mm",
        "ACS® FB trial PE insert ultra 6 10mm",
        "ACS® FB trial PE insert PS 3/12,5mm",
        "ACS® FB trial PE insert SC 4/13,75mm",
        "MK trial femoral spacer distal rl/lm 2/5mm",
        "ACS® FB trial PE insert PS 5/13,75mm",
        "ACS® FB tibial trial spacer ll/rm 3,5/10mm",
        "ACS® FB tibial trial spacer rl/lm 3/10mm",
        "ACS® FB trial PE insert hyperflex 4/13,75mm",
        "ACS® FB trial PE insert SC 2/13,75mm",
        "ACS® FB trial PE insert ultra 3/11,25mm"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3011274144",
        "fei_number": "3011274144",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "WESTLAKE PLASTICS EUROPE",
        "address_line_1": "2 rue de Maestricht",
        "address_line_2": "",
        "city": "TOURCOING Nord",
        "state_code": "",
        "iso_country_code": "FR",
        "zip_code": "",
        "postal_code": "59200",
        "us_agent": {
          "name": "Yared Mengistu",
          "business_name": "Westlake Plastics Company",
          "bus_phone_area_code": "610",
          "bus_phone_num": "4591000",
          "bus_phone_extn": "2326",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "yared.mengistu@westlakeplastics.com",
          "address_line_1": "490 W. Lenni Road",
          "address_line_2": "",
          "city": "Lenni",
          "state_code": "PA",
          "iso_country_code": "US",
          "zip_code": "19052",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "WESTLAKE PLASTICS EUROPE",
          "owner_operator_number": "10048274",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "2 rue de Maestricht",
            "address_2": "",
            "city": "TOURCOING",
            "state_code": "FR-59",
            "state_province": "Nord",
            "iso_country_code": "FR",
            "postal_code": "59200"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "HWT",
          "created_date": "2017-04-11",
          "owner_operator_number": "10048274",
          "exempt": "",
          "openfda": {
            "device_name": "Template",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.4800",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}