BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Inset Reverse Total Shoulder System

    Reg #: 1836116 · FEI: 3002687954 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    REVELATION MEDICAL DEVICES, LLC
    Registration Number
    1836116
    FEI Number
    3002687954
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1105 West Auburn Street
    City
    Auburn
    State
    IN
    ZIP
    46706
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210533

    Owner / Operator

    Firm Name
    REVELATION MEDICAL DEVICES LLC
    Operator Number
    10051413
    Address
    1105 WEST AUBURN DRIVE
    City
    Auburn
    State
    IN
    Postal Code
    46706
    Country
    US

    Products

    Device Name Product Code
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF

    Proprietary Names

    Inset Reverse Total Shoulder System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)