{
  "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": "2026-09-07",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "proprietary_name": [
        "Trial Acetabular Cup, Size 58mm",
        "Drill Guide",
        "Stem Positioner",
        "Trial Femoral Head, 28mm, S",
        "Kratos Trial Neck, H/O (Lateralized)",
        "Trial Liner, Neutral, 28mm Head, Size 48 50mm",
        "Trial Femoral Head, 36mm, XL",
        "Trial Liner, 10, 32mm Head, Size 56 58mm",
        "Trial Acetabular Cup, Size 52mm",
        "Trial Liner, Neutral, 28mm Head, Size 52 54mm",
        "Quick Release Stem Impactor",
        "Tryon 2 Tray",
        "Trial Liner, Neutral, 32mm Head, Size 56 58mm",
        "Trial Liner, Neutral, 28mm Head, Size 44 46mm",
        "Quick Release Box Osteotome",
        "Trial Acetabular Cup, Size 44mm",
        "Trial Liner, 10, 36mm Head, Size 60 62mm",
        "Screw Inserter",
        "Tray, Bonded Stem",
        "IM Drill",
        "Stepped Entry Reamer",
        "Trial Acetabular Cup, Size 46mm",
        "Straight Broach Handle",
        "Kratos Trial Neck, Standard",
        "Alignment Guide",
        "Trial Liner, Neutral, 36mm Head, Size 56 58mm",
        "Trial Acetabular Cup, Size 50mm",
        "Reamer Shaft",
        "Trial Acetabular Cup, Size 62mm",
        "Trial Acetabular Cup, Size 64mm",
        "Trial Femoral Head, 32mm, L",
        "Trial Femoral Head, 36mm, M",
        "Trial Liner, 10, 36mm Head, Size 56 58mm",
        "Trial Liner, Neutral, 36mm Head, Size 60 68mm",
        "Drill Depth Gauge",
        "Broach Handle power adapter",
        "Trial Liner, 10, 36mm Head, Size 52 54mm",
        "Trial Acetabular Cup, Size 60mm",
        "Trial Liner, 10, 32mm Head, Size 52 54mm",
        "Large Reamer Handle",
        "Trial Liner, Neutral, 32mm Head, Size 52 54mm",
        "Liner Impactor, 32mm",
        "Quick Connect Drill Shaft",
        "Trial Liner, 10, 32mm Head, Size 60 68mm",
        "Trial Femoral Head, 36mm, L",
        "Trial Femoral Head, 32mm, M",
        "Liner Impactor, 28mm",
        "Trial Acetabular Cup, Size 66mm",
        "Trial Femoral Head, 28mm, M",
        "Stem Impactor",
        "Trial Femoral Head, 32mm, S",
        "Trial Femoral Head, 36mm, S",
        "Osteotomy Guide",
        "Screw Driver Handle",
        "Trial Acetabular Cup, Size 56mm",
        "Trial Liner, 10, 28mm Head, Size 52 54mm",
        "Trial Acetabular Cup, Size 54mm",
        "Trial Liner, Neutral, 32mm Head, Size 48 50mm",
        "Trial Acetabular Cup, Size 48mm",
        "Trial Acetabular Cup, Size 68mm",
        "Tapered Pin Reamer",
        "3.5 Hex Screw Driver Shaft",
        "Calcar Reamer, Large",
        "Trial Liner, 10, 28mm Head, Size 48 50mm",
        "Quick Release Head Impactor",
        "Trial Liner, Neutral, 36mm Head, Size 52 54mm",
        "Trial Liner, Neutral, 32mm Head, Size 60 68mm",
        "Trial Femoral Head, 28mm, L",
        "Trial Femoral Head, 32mm, XL",
        "Trial Liner, 10, 28mm Head, Size 44 46mm",
        "Straight Cup Inserter",
        "Liner Impactor, 36mm",
        "Trial Liner, 10, 32mm Head, Size 48 50mm",
        "Tray, Tryon Acetabular System",
        "Dymaxeon Spine System"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3008840738",
        "fei_number": "3008840738",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "HAMAGAWA INDUSTRIAL (M) SDN BHD",
        "address_line_1": "Lot 26, Jalan 8",
        "address_line_2": "Bakar Arang Industrial Estate",
        "city": "Sungai Petani Kedah",
        "state_code": "",
        "iso_country_code": "MY",
        "zip_code": "",
        "postal_code": "08000",
        "us_agent": {
          "name": "Jeremy Tincher",
          "business_name": "",
          "bus_phone_area_code": "901",
          "bus_phone_num": "3312747",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "jeremy@signatureortho.us",
          "address_line_1": "3150 Stage Post Drive",
          "address_line_2": "Suite 104",
          "city": "Bartlett",
          "state_code": "TN",
          "iso_country_code": "US",
          "zip_code": "38133",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "HAMAGAWA INDUSTRIAL (M) SDN BHD",
          "owner_operator_number": "10047158",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "Lot 26, Jalan 8",
            "address_2": "Bakar Arang Industrial Estate",
            "city": "Sungai Petani",
            "state_code": "MY-02",
            "state_province": "Kedah",
            "iso_country_code": "MY",
            "postal_code": "08000"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "LXH",
          "created_date": "2014-07-08",
          "owner_operator_number": "10047158",
          "exempt": "",
          "openfda": {
            "device_name": "Orthopedic Manual Surgical Instrument",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.4540",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}