BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Truliant CRC tibial insert, size 1.5, 10mm

    Reg #: 3008658204 · FEI: 3008658204 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    210
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Exactech Sarasota
    Registration Number
    3008658204
    FEI Number
    3008658204
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7455 16th Street East, Suite 105
    City
    Sarasota
    State
    FL
    ZIP
    34243
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171045

    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 CRC tibial insert, size 1.5, 10mm Truliant CR Neutral tibial insert, size 2.5, 10mm Truliant CR Neutral tibial insert, size 4.5, 15mm Truliant CR Neutral tibial insert, size 4.5, 11mm Truliant CR Neutral tibial insert, size 3, 14mm Truliant CR Slope ++ tibial insert, size 0, 10mm Truliant PS tibial insert, size 4, 12mm Truliant CR Neutral tibial insert, size 2, 12mm Truliant CRC tibial insert, size 5, 14mm Truliant PS tibial insert, size 4.5, 10mm Truliant CRC tibial insert, size 0, 12mm Truliant PS tibial insert, size 4.5, 11mm Truliant PSC tibial insert, size 4.5, 13mm Truliant PS tibial insert, size 2, 12mm Truliant PSC tibial insert, size 4.5, 19mm Truliant CRC tibial insert, size 3.5, 14mm Truliant PS tibial insert, size 1, 14mm Truliant CRC tibial insert, size 4.5, 13mm Truliant PSC tibial insert, size 4.5, 17mm Truliant CRC tibial insert, size 4.5, 12mm Truliant CR Slope ++ tibial insert, size 2, 10mm Truliant CR Slope + tibial insert, size 2, 10mm Truliant CR Neutral tibial insert, size 4.5, 12mm Truliant CR Slope ++ tibial insert, size 2.5, 12mm Truliant PSC tibial insert, size 3, 12mm Truliant CR Slope ++ tibial insert, size 3, 12mm Truliant CR Slope ++ tibial insert, size 3.5, 12mm Truliant CR Neutral tibial insert, size 6, 10mm Truliant CR Neutral tibial insert, size 2, 14mm Truliant CR Neutral tibial insert, size 0, 14mm Truliant CR Slope ++ tibial insert, size 4, 10mm Truliant PS tibial insert, size 4, 14mm Truliant CR Slope ++ tibial insert, size 2.5, 10mm Truliant PS tibial insert, size 1.5, 12mm Truliant CR Slope ++ tibial insert, size 5, 12mm Truliant CRC tibial insert, size 4.5, 11mm Truliant CRC tibial insert, size 5, 12mm Truliant CRC tibial insert, size 2, 10mm Truliant CR Slope + tibial insert, size 5, 10mm Truliant CRC tibial insert, size 4.5, 15mm Truliant CR Slope ++ tibial insert, size 1, 10mm Truliant CR Slope + tibial insert, size 4.5, 10mm Truliant PSC tibial insert, size 6, 10mm Truliant PS tibial insert, size 4.5, 15mm Truliant CRC tibial insert, size 5, 10mm Truliant PSC tibial insert, size 0, 12mm Truliant CRC tibial insert, size 1, 10mm Truliant CR Neutral tibial insert, size 1, 10mm Truliant PS tibial insert, size 1.5, 10mm Truliant PS tibial insert, size 4, 10mm Truliant CR Slope ++ tibial insert, size 3.5, 10mm Truliant CR Neutral tibial insert, size 4.5, 13mm Truliant PSC tibial insert, size 2.5, 14mm Truliant PS tibial insert, size 4.5, 13mm Truliant CR Neutral tibial insert, size 3, 10mm Truliant PSC tibial insert, size 5, 12mm Truliant Fit tibial tray, cemented, size 4.5F/3.5T Truliant CR Neutral tibial insert, size 5, 12mm Truliant CR Slope + tibial insert, size 3.5, 12mm Truliant CR Slope + tibial insert, size 0, 10mm Truliant CR Slope + tibial insert, size 5, 12mm Truliant PS tibial insert, size 1.5, 14mm Truliant CR Cemented Femoral, size 4.5 Left Truliant CRC tibial insert, size 6, 10mm Truliant CR Slope + tibial insert, size 1.5, 10mm Truliant CRC tibial insert, size 3.5, 10mm Truliant PS Cemented Femoral, size 4.5 Left Truliant Fit tibial tray, cemented, size 4.5F/4.5T Truliant CR Neutral tibial insert, size 4.5, 14mm Truliant PS tibial insert, size 3, 14mm Truliant PSC tibial insert, size 4.5, 11mm Truliant CR Neutral tibial insert, size 2, 10mm Truliant CR Slope + tibial insert, size 3, 12mm Truliant PS tibial insert, size 3.5, 14mm Truliant CRC tibial insert, size 2, 14mm Truliant CRC tibial insert, size 4.5, 17mm Truliant CR Neutral tibial insert, size 4, 12mm Truliant CRC tibial insert, size 1, 12mm Truliant PSC tibial insert, size 1.5, 14mm Truliant CR Neutral tibial insert, size 6, 12mm Truliant CRC tibial insert, size 4, 12mm Truliant CRC tibial insert, size 4.5, 14mm Truliant PS tibial insert, size 3.5, 10mm Truliant CR Neutral tibial insert, size 6, 14mm Truliant Fit tibial tray, cemented, size 4.5F/5.5T Truliant CR Neutral tibial insert, size 1.5, 12mm Truliant CRC tibial insert, size 2.5, 14mm Truliant PS tibial insert, size 3, 10mm Truliant PS tibial insert, size 6, 10mm Truliant CRC tibial insert, size 0, 14mm Truliant PS tibial insert, size 1, 12mm Truliant CR Slope + tibial insert, size 6, 12mm Truliant CRC tibial insert, size 1.5, 14mm Truliant PS tibial insert, size 4.5, 14mm Truliant PSC tibial insert, size 1, 10mm Truliant CR Neutral tibial insert, size 2.5, 14mm Truliant PSC tibial insert, size 5, 14mm Truliant CR Neutral tibial insert, size 5, 14mm Truliant PS tibial insert, size 2.5, 12mm Truliant CR Neutral tibial insert, size 5, 10mm Truliant CR Neutral tibial insert, size 3.5, 12mm Truliant CR Slope + tibial insert, size 3.5, 10mm Truliant CR Neutral tibial insert, size 0, 12mm Truliant CR Slope ++ tibial insert, size 5, 10mm Truliant PSC tibial insert, size 2, 14mm Truliant PSC tibial insert, size 2, 12mm Truliant CR Slope + tibial insert, size 2.5, 10mm Truliant CR Slope ++ tibial insert, size 4.5, 12mm Truliant CR Slope + tibial insert, size 3, 10mm Truliant PS tibial insert, size 5, 12mm Truliant PSC tibial insert, size 2.5, 12mm Truliant CR Neutral tibial insert, size 4, 10mm Truliant PS tibial insert, size 4.5, 17mm Truliant PSC tibial insert, size 4, 12mm Truliant CR Neutral tibial insert, size 4.5, 10mm Truliant CR Slope + tibial insert, size 4.5, 9mm Truliant CR Neutral tibial insert, size 3.5, 14mm Truliant PSC tibial insert, size 4, 10mm Truliant PSC tibial insert, size 6, 14mm Truliant PS tibial insert, size 5, 10mm Truliant PSC tibial insert, size 4.5, 15mm Truliant PSC tibial insert, size 4.5, 12mm Truliant CR Slope ++ tibial insert, size 4.5, 9mm Truliant CR Slope ++ tibial insert, size 1, 12mm Truliant PS Cemented Femoral, size 4.5 Right Truliant CRC tibial insert, size 1, 14mm Truliant PS tibial insert, size 0, 12mm Truliant PS tibial insert, size 4.5, 12mm Truliant CR Slope + tibial insert, size 1.5, 12mm Truliant PS tibial insert, size 2.5, 14mm Truliant PS tibial insert, size 6, 12mm Truliant CR Neutral tibial insert, size 1.5, 14mm Truliant CR Slope + tibial insert, size 2, 12mm Truliant CRC tibial insert, size 2.5, 10mm Truliant PSC tibial insert, size 1, 12mm Truliant PSC tibial insert, size 3.5, 14mm Truliant CRC tibial insert, size 3, 10mm Truliant PS tibial insert, size 4.5, 19mm Truliant PSC tibial insert, size 4, 14mm Truliant CR Slope ++ tibial insert, size 4.5, 11mm Truliant CR Neutral tibial insert, size 4, 14mm Truliant PS tibial insert, size 5, 14mm Truliant CR Slope + tibial insert, size 2.5, 12mm Truliant CRC tibial insert, size 2, 12mm Truliant CR Neutral tibial insert, size 2.5, 12mm Truliant CRC tibial insert, size 4, 14mm Truliant CR Neutral tibial insert, size 4.5, 17mm Truliant CRC tibial insert, size 3, 12mm Truliant PSC tibial insert, size 1.5, 10mm Truliant PS tibial insert, size 1, 10mm Truliant CRC tibial insert, size 4.5, 19mm Truliant CRC tibial insert, size 4.5, 10mm Truliant CR Slope ++ tibial insert, size 2, 12mm Truliant CR Slope ++ tibial insert, size 6, 12mm Truliant CR Slope + tibial insert, size 1, 10mm Truliant CR Slope ++ tibial insert, size 1.5, 10mm Truliant PSC tibial insert, size 2.5, 10mm Truliant CR Slope ++ tibial insert, size 4, 12mm Truliant PS tibial insert, size 3, 12mm Truliant CR Neutral tibial insert, size 4.5, 9mm Truliant PS tibial insert, size 4.5, 9mm Truliant PS tibial insert, size 2, 10mm Truliant PSC tibial insert, size 3.5, 10mm Truliant CRC tibial insert, size 4.5, 9mm Truliant CR Slope + tibial insert, size 4.5, 12mm Truliant CR Neutral tibial insert, size 1.5, 10mm Truliant PS tibial insert, size 0, 14mm Truliant CR Neutral tibial insert, size 1, 12mm Truliant CRC tibial insert, size 2.5, 12mm Truliant CR Slope + tibial insert, size 0, 12mm Truliant PS tibial insert, size 2, 14mm Truliant CR Slope + tibial insert, size 1, 12mm Truliant PS tibial insert, size 0, 10mm Truliant CR Slope + tibial insert, size 4.5, 13mm Truliant CR Neutral tibial insert, size 0, 10mm Truliant CR Neutral tibial insert, size 1, 14mm Truliant CR Slope ++ tibial insert, size 1.5, 12mm Truliant CR Slope + tibial insert, size 4.5, 11mm Truliant CRC tibial insert, size 3, 14mm Truliant PSC tibial insert, size 4.5, 9mm Truliant PSC tibial insert, size 4.5, 10mm Truliant CR Slope + tibial insert, size 4, 12mm Truliant PS tibial insert, size 6, 14mm Truliant CR Cemented Femoral, size 4.5 Right Truliant CR Slope ++ tibial insert, size 4.5, 13mm Truliant CRC tibial insert, size 4, 10mm Truliant PSC tibial insert, size 3.5, 12mm Truliant PSC tibial insert, size 2, 10mm Truliant PSC tibial insert, size 3, 10mm Truliant CRC tibial insert, size 0, 10mm Truliant PS tibial insert, size 2.5, 10mm Truliant CR Slope + tibial insert, size 4, 10mm Truliant PSC tibial insert, size 5, 10mm Truliant CRC tibial insert, size 6, 14mm Truliant CR Slope ++ tibial insert, size 3, 10mm Truliant PSC tibial insert, size 6, 12mm Truliant PSC tibial insert, size 1.5, 12mm Truliant PSC tibial insert, size 0, 10mm Truliant CR Neutral tibial insert, size 3.5, 10mm Truliant PSC tibial insert, size 1, 14mm Truliant PSC tibial insert, size 3, 14mm Truliant CRC tibial insert, size 6, 12mm Truliant CRC tibial insert, size 1.5, 12mm Truliant CR Neutral tibial insert, size 3, 12mm Truliant PS tibial insert, size 3.5, 12mm Truliant CR Slope ++ tibial insert, size 4.5, 10mm Truliant PSC tibial insert, size 0, 14mm Truliant CR Slope ++ tibial insert, size 0, 12mm Truliant PSC tibial insert, size 4.5, 14mm Truliant CRC tibial insert, size 3.5, 12mm

    Establishment Types

    Manufacture Medical Device