{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 10
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Shoulder Innovations Total Shoulder Replacement System"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "1836116",
        "fei_number": "3002687954",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "REVELATION MEDICAL DEVICES, LLC",
        "address_line_1": "1105 West Auburn Street",
        "address_line_2": "",
        "city": "Auburn",
        "state_code": "IN",
        "iso_country_code": "US",
        "zip_code": "46706",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "REVELATION MEDICAL DEVICES LLC",
          "owner_operator_number": "10051413",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "1105 WEST AUBURN DRIVE",
            "address_2": "",
            "city": "Auburn",
            "state_code": "IN",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "46706"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "KWS",
          "created_date": "2023-09-19",
          "owner_operator_number": "10051413",
          "exempt": "",
          "openfda": {
            "device_name": "Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3660",
            "device_class": "2"
          }
        },
        {
          "product_code": "HSD",
          "created_date": "2023-09-19",
          "owner_operator_number": "10051413",
          "exempt": "",
          "openfda": {
            "device_name": "Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3690",
            "device_class": "2"
          }
        },
        {
          "product_code": "KWT",
          "created_date": "2023-09-19",
          "owner_operator_number": "10051413",
          "exempt": "",
          "openfda": {
            "device_name": "Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3650",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}