BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Universal2 Total Wrist Implant System

    Reg #: 1827096 · FEI: 1827096 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORCHID ORTHOPEDICS-CHELSEA
    Registration Number
    1827096
    FEI Number
    1827096
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    13800 Luick Dr
    City
    Chelsea
    State
    MI
    ZIP
    48118
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030037

    Owner / Operator

    Firm Name
    Orchid Orthopedic Solutions
    Operator Number
    10042895
    Address
    13800 Luick Drive
    City
    Chelsea
    State
    MI
    Postal Code
    48118
    Country
    US
    Correspondent
    Albert A DeWalt

    Products

    Device Name Product Code
    Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained JWJ

    Proprietary Names

    Universal2 Total Wrist Implant System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)