BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zimmer Nexel Total Elbow

    Reg #: 1834179 · FEI: 1000160371 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Haven Manufacturing
    Registration Number
    1834179
    FEI Number
    1000160371
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6935 N State Road 1
    City
    OSSIAN
    State
    IN
    ZIP
    46777
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123862

    Owner / Operator

    Firm Name
    CADREX /Haven Manufacturing Indiana
    Operator Number
    9008697
    Address
    6935 N. State Road 1
    City
    Ossian
    State
    IN
    Postal Code
    46777
    Country
    US
    Correspondent
    Leigh Chen

    Products

    Device Name Product Code
    Prosthesis, Elbow, Constrained, Cemented JDC

    Proprietary Names

    Zimmer Nexel Total Elbow

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)