{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "true",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 47 for head dia. 28 mm",
      "public_device_record_key": "46f13de8-b4a5-473f-9d94-12bc49de0ced",
      "has_serial_number": "false",
      "public_version_date": "2020-09-09",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "4",
      "labeler_duns_number": "432066322",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "08033390009751",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "Bipolar Head",
      "has_manufacturing_date": "false",
      "brand_name": "LOCK",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "KWZ",
          "name": "Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer",
          "openfda": {
            "device_name": "Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3310",
            "device_class": "2"
          }
        },
        {
          "code": "KWY",
          "name": "Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented",
          "openfda": {
            "device_name": "Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3390",
            "device_class": "2"
          }
        },
        {
          "code": "JDI",
          "name": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented",
          "openfda": {
            "device_name": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3350",
            "device_class": "2"
          }
        },
        {
          "code": "LPH",
          "name": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented",
          "openfda": {
            "device_name": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3358",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K112158",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "catalog_number": "5527.09.470",
      "company_name": "LIMACORPORATE SPA",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "33695",
          "name": "Bipolar femoral head outer component, hemiarthroplasty",
          "definition": "An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.",
          "implantable": "true",
          "code_status": "Active"
        }
      ],
      "publish_date": "2015-07-31",
      "device_sizes": [
        {
          "type": "Device Size Text, specify",
          "text": "Dia. 47mm For Heads 28mm"
        }
      ]
    }
  ]
}