{
  "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": 22
    }
  },
  "results": [
    {
      "proprietary_name": [
        "K-Wire Sleeve Insert",
        "Orthopedic Manual Surgical Instrument",
        "LITe Funnel",
        "Bone Tap",
        "Locking Drill IMN Instruments ø4.2x360mm",
        "Freehand Drill IMN Instruments ø3.5x185mm",
        "Drill Gauge (Percutaneous)",
        "Drilling Guide ø3.2/4.5",
        "\"Insertion Sleeve for ø3.2mm Guide Wires\"",
        "Drill Guide ø6.55",
        "Drilling Guide ø2.5/3.5",
        "Freehand Drill IMN Instruments ø3.5x130mm",
        "Freehand Drill IMN Instruments ø4.2x185mm",
        "Guide Wire D3.2xL300",
        "Trocar SPS-MonoAxial Locking Set 5mm",
        "Inserter sleeve",
        "Lag Screw Depth Gauge",
        "Tissue prot. sleeve ø6.5/4.5",
        "Depth Gauge 0-150mm for Screws: ø4.5/6.5mm",
        "Insert ø2.5 compression",
        "Trocar SPS-MonoAxial Locking Set 4mm",
        "Drill Sleeve D4.3",
        "Direct Measuring Gauge",
        "Zimmer Biomet",
        "Drilling Guide ø2/2.7",
        "Drill Guide Supracondylar",
        "Depth Gauge 0-70mm for Screws: ø2.7/3.5/4mm",
        "Locking Drill IMN Instruments ø3.5x360mm",
        "Threaded Guide Wire D3.2xL300",
        "Freehand Drill IMN Instruments ø4.2x130mm",
        "Depth Gauge 0-110mm For Screws ø2.7/3.5/4",
        "Guide Wire D3xL300",
        "Depth Gauge 0-150mm for Screws: ø2.7/3.5/4mm",
        "Depth Gauge 0-120mm",
        "Insert ø3.2 compression",
        "Drill Sleeve Handle",
        "Drill Sleeve D3.1",
        "Screw Insertion Sleeve ø9mm",
        "Parallel Drill Guide",
        "Insert ø2.5 neutral",
        "Guide Wire D3.2xL300 (Sterile)",
        "Insert ø2.5 support",
        "Insert ø3.2 neutral",
        "Lag Screw Tap Sleeve",
        "Threaded Guide Wire D3.2xL300 (Sterile)",
        "Guide Wire",
        "IMN™ Instruments",
        "INSERTION SHIM - HANDLE",
        "C-STEM AMT HO NECK SEGMENT- SZ2/3",
        "C-STEM AMT STD NECK SEGMENT- SZ6/7",
        "Guide Wire with Ruler Tube",
        "C-STEM AMT STD NECK SEGMENT- SZ0/1",
        "C-STEM AMT SZ 3A NK SEGMENT",
        "Distractor Twist Drill",
        "Drill Sleeve Insert",
        "C-STEM AMT SZ 2A NK SEGMENT",
        "Centerpiece Plate Fixation System",
        "C-STEM AMT HO NECK SEGMENT- SZ4/5",
        "3MM DRILL BIT, LONG",
        "C-STEM AMT HO NECK SEGMENT- SZ 0/1",
        "C-STEM AMT STD NECK SEGMENT- SZ2/3"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3009141957",
        "fei_number": "3009141957",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "AMETEK Poland sp. z o.o.",
        "address_line_1": "Ul. Stanislawa Staszica 5",
        "address_line_2": "",
        "city": "Siechnice Dolnoslaskie",
        "state_code": "",
        "iso_country_code": "PL",
        "zip_code": "",
        "postal_code": "55-011",
        "us_agent": {
          "name": "Stephane Langlois",
          "business_name": "Paragon Medical",
          "bus_phone_area_code": "435",
          "bus_phone_num": "5355456",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "stephane.langlois@ametek.com",
          "address_line_1": "8 Matchett Dr",
          "address_line_2": "",
          "city": "Pierceton",
          "state_code": "IN",
          "iso_country_code": "US",
          "zip_code": "46562",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Paragon Medical",
          "owner_operator_number": "9011072",
          "official_correspondent": {
            "first_name": "Stephane",
            "middle_initial": "",
            "last_name": "Langlois",
            "subaccount_company_name": "",
            "phone_number": "001-435-5355456-x"
          },
          "contact_address": {
            "address_1": "8 Matchett Dr.",
            "address_2": "--",
            "city": "Pierceton",
            "state_code": "IN",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "46562"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "LXH",
          "created_date": "2007-12-28",
          "owner_operator_number": "9011072",
          "exempt": "",
          "openfda": {
            "device_name": "Orthopedic Manual Surgical Instrument",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.4540",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}