{
  "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,
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  },
  "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": "MANZA HA NON-CEMENTED CUP NO HOLE, 42MM",
      "public_device_record_key": "780f40a9-b7e2-4596-93ca-519b22629e3c",
      "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": "080460688",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00841176100558",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "101-00-042",
      "has_manufacturing_date": "true",
      "brand_name": "MANZA HA NON-CEMENTED CUP",
      "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": "MEH",
          "name": "Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate",
          "openfda": {
            "device_name": "Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3353",
            "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": "K153131",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "catalog_number": "101-00-042",
      "company_name": "STINSON ORTHOPEDICS INC.",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "43167",
          "name": "Acetabular shell",
          "definition": "An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.",
          "implantable": "true",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-12-26"
    }
  ]
}