BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Truliant PS Cemented Femoral, size 1 Right

    Reg #: 1038671 · FEI: 1038671 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    41
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    EXACTECH, INC.
    Registration Number
    1038671
    FEI Number
    1038671
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2320 N.W. 66TH CT.
    City
    GAINESVILLE
    State
    FL
    ZIP
    32653
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170240

    Owner / Operator

    Firm Name
    EXACTECH, INC.
    Operator Number
    1038671
    Address
    2320 N.W. 66TH CT., --
    City
    Gainesville
    State
    FL
    Postal Code
    32653
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    Truliant PS Cemented Femoral, size 1 Right Truliant CR Cemented Femoral, size 1.5 Right Truliant PS Cemented Femoral, size 0 Right Truliant CR Cemented Femoral, size 5 Right Truliant PS Cemented Femoral, size 3.5 Right Truliant CR Cemented Femoral, size 3.5 Left Truliant CR Cemented Femoral, size 0 Right Truliant CR Cemented Femoral, size 6 Left Truliant CR Cemented Femoral, size 3 Left Truliant PS Cemented Femoral, size 4 Right Truliant PS Cemented Femoral, size 3.5 Left Truliant CR Cemented Femoral, size 4 Left Truliant PS Cemented Femoral, size 4 Left Truliant CR Cemented Femoral, size 3.5 Right Truliant PS Cemented Femoral, size 1 Left Truliant Cemented Femoral Component Truliant PS Cemented Femoral, size 3 Left Truliant PS Cemented Femoral, size 2 Right Truliant CR Cemented Femoral, size 1 Right Truliant CR Cemented Femoral, size 6 Right Truliant CR Cemented Femoral, size 0 Left Truliant CR Cemented Femoral, size 2.5 Right Truliant CR Cemented Femoral, size 1 Left Truliant PS Cemented Femoral, size 1.5 Right Truliant PS Cemented Femoral, size 2 Left Truliant PS Cemented Femoral, size 6 Left Truliant PS Cemented Femoral, size 5 Right Truliant PS Cemented Femoral, size 2.5 Left Truliant PS Cemented Femoral, size 2.5 Right Truliant CR Cemented Femoral, size 1.5 Left Truliant CR Cemented Femoral, size 3 Right Truliant CR Cemented Femoral, size 2 Left Truliant PS Cemented Femoral, size 0 Left Truliant PS Cemented Femoral, size 6 Right Truliant CR Cemented Femoral, size 5 Left Truliant CR Cemented Femoral, size 2.5 Left Truliant PS Cemented Femoral, size 1.5 Left Truliant PS Cemented Femoral, size 3 Right Truliant CR Cemented Femoral, size 4 Right Truliant CR Cemented Femoral, size 2 Right Truliant PS Cemented Femoral, size 5 Left

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device