BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Exactech Sarasota

    Reg #: 3008658204 · FEI: 3008658204 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    250
    Establishment Types
    1
    Classifications
    12

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    Registration Details

    Registration Name
    Exactech Sarasota
    Registration Number
    3008658204
    FEI Number
    3008658204
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7455 16th Street East, Suite 105
    City
    Sarasota
    State
    FL
    ZIP
    34243
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103419

    Owner / Operator

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

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Orthopedic Manual Surgical Instrument LXH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Plate, Fixation, Bone HRS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Bit, Drill HTW

    Proprietary Names

    Equinoxe UHMWPE Posterior Augment Pegged Glenoids Optetrak Logic CR Alteon Bone Screws KNEE ORTHOPEDIC SURGICAL INSTRUMEN EXACTECH HIP TS Optetrak 9mm CR Tibial Insert Slope Optetrak Knee offset Tibial Tray Logic PSC Tibial Insert TRULIANT Porous Tibial Tray Equinoxe Reverse Shoulder System Logic PS OPTETRAK UNICONDYLAR KNEE Cruciate Retaining Cemented Knee Cruciate Retaining Cemented Tibial Optetrak Logic CR Knee System Equinoxe Fracture Plate Equinoxe Equinoxe Fixed Angle Replicator Plates Equinoxe Cast Glenospheres Equinoxe Cast Humeral Heads Optetrak Logic CRC Tibial Inserts Exactech Equinoxe Short Replicator Plates Equinoxe Reverse Shoulder Superior Augment Glenoid Plate Equinoxe Reverse Shoulder 38mm and 42mm Glensopheres Equinoxe Reverse Shoulder Glenoid Plate Equinoxe Reverse Shoulder Compression Screw Equinoxe Reverse Shoulder Posterior Augment Glenoid Plate Optetrak HiFlex Aysm PS Cemnt Fmrl Optetrak HiFlex PS Tibial Insert Optetrak Constrained Condylar Knee Equinoxe Cage Glenoid Cemented Total Knee Sys Tibial Comp Vantage Total Ankle System Truliant CRC tibial insert, size 5, 12mm Truliant CR Slope + tibial insert, size 5, 10mm Truliant CR Slope ++ tibial insert, size 2, 12mm Truliant CRC tibial insert, size 3, 12mm Truliant CR Slope + tibial insert, size 4.5, 10mm Truliant CR Slope + tibial insert, size 1, 10mm Truliant CRC tibial insert, size 4.5, 19mm Truliant PSC tibial insert, size 6, 10mm Truliant CR Neutral tibial insert, size 5, 14mm Truliant PS tibial insert, size 2.5, 12mm 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 PSC tibial insert, size 4, 10mm Truliant CR Slope + tibial insert, size 4.5, 11mm Truliant CRC tibial insert, size 3.5, 10mm Truliant CR Cemented Femoral, size 4.5 Left Truliant CR Slope ++ tibial insert, size 4, 12mm Truliant CR Slope + tibial insert, size 1.5, 10mm Truliant PSC tibial insert, size 3.5, 14mm Truliant CRC tibial insert, size 3, 10mm Truliant CR Slope ++ tibial insert, size 4.5, 12mm Truliant PS tibial insert, size 4.5, 9mm Truliant PS tibial insert, size 4.5, 19mm Truliant PSC tibial insert, size 2.5, 12mm Truliant CR Slope ++ tibial insert, size 4.5, 11mm Truliant PSC tibial insert, size 3.5, 12mm Truliant PSC tibial insert, size 2, 10mm Truliant CR Neutral tibial insert, size 4, 14mm Truliant CRC tibial insert, size 0, 10mm Truliant CR Slope + tibial insert, size 5, 12mm Truliant PS tibial insert, size 1.5, 14mm Truliant PS Cemented Femoral, size 4.5 Left Truliant CRC tibial insert, size 6, 10mm Truliant Fit tibial tray, cemented, size 4.5F/4.5T Truliant CR Neutral tibial insert, size 4.5, 14mm Truliant CR Slope + tibial insert, size 2, 12mm Truliant PS tibial insert, size 3, 14mm Truliant CRC tibial insert, size 2, 12mm Truliant CRC tibial insert, size 2, 14mm Truliant CR Slope + tibial insert, size 4, 10mm Truliant PS tibial insert, size 3.5, 12mm Truliant CRC tibial insert, size 0, 12mm Truliant PSC tibial insert, size 3, 14mm Truliant CR Slope ++ tibial insert, size 4.5, 10mm Truliant PSC tibial insert, size 4.5, 19mm Truliant CRC tibial insert, size 1.5, 12mm Truliant PSC tibial insert, size 4.5, 14mm Truliant CR Slope ++ tibial insert, size 0, 10mm Truliant PSC tibial insert, size 4.5, 15mm Truliant CR Neutral tibial insert, size 0, 12mm Truliant PSC tibial insert, size 2, 12mm Truliant PS Cemented Femoral, size 4.5 Right Truliant CR Slope ++ tibial insert, size 4, 10mm Truliant CRC tibial insert, size 1.5, 14mm Truliant CR Slope ++ tibial insert, size 2.5, 10mm Truliant CRC tibial insert, size 4.5, 12mm Truliant CR Slope ++ tibial insert, size 5, 12mm Truliant PSC tibial insert, size 5, 14mm Truliant CR Neutral tibial insert, size 4.5, 9mm Truliant CRC tibial insert, size 4, 12mm Truliant CRC tibial insert, size 4.5, 14mm Truliant PSC tibial insert, size 3.5, 10mm Truliant CR Neutral tibial insert, size 6, 14mm Truliant CRC tibial insert, size 4.5, 9mm Truliant CR Neutral tibial insert, size 1.5, 10mm Truliant PS tibial insert, size 0, 14mm Truliant CRC tibial insert, size 2.5, 12mm Truliant CRC tibial insert, size 2, 10mm Truliant CR Slope + tibial insert, size 2, 10mm Truliant CR Slope + tibial insert, size 1, 12mm Truliant CR Neutral tibial insert, size 4, 12mm Truliant CR Slope ++ tibial insert, size 3, 10mm Truliant PS tibial insert, size 0, 12mm Truliant PSC tibial insert, size 0, 10mm Truliant CR Slope + tibial insert, size 1.5, 12mm Truliant CR Neutral tibial insert, size 4.5, 10mm Truliant CR Neutral tibial insert, size 1.5, 12mm Truliant CRC tibial insert, size 2.5, 14mm Truliant CR Neutral tibial insert, size 3.5, 14mm Truliant PS tibial insert, size 3, 10mm Truliant CRC tibial insert, size 6, 12mm Truliant CRC tibial insert, size 0, 14mm Truliant Fit tibial tray, cemented, size 4.5F/5.5T Truliant CR Slope + tibial insert, size 4.5, 9mm Truliant CR Slope ++ tibial insert, size 1.5, 12mm Truliant PSC tibial insert, size 6, 14mm Truliant PSC tibial insert, size 4.5, 9mm Truliant PS tibial insert, size 2, 12mm Truliant CR Neutral tibial insert, size 2, 10mm Truliant CRC tibial insert, size 3.5, 14mm Truliant PS tibial insert, size 3.5, 14mm Truliant CRC tibial insert, size 4.5, 17mm Truliant CR Neutral tibial insert, size 0, 14mm Truliant PS tibial insert, size 6, 12mm Truliant CRC tibial insert, size 2.5, 10mm Truliant PSC tibial insert, size 4.5, 11mm Truliant PS tibial insert, size 0, 10mm Truliant CR Slope + tibial insert, size 4, 12mm Truliant CR Neutral tibial insert, size 5, 10mm Truliant CRC tibial insert, size 4, 10mm Truliant CR Neutral tibial insert, size 3.5, 12mm Truliant CR Neutral tibial insert, size 1, 12mm Truliant CRC tibial insert, size 4.5, 11mm Truliant CR Slope + tibial insert, size 0, 12mm Truliant PS tibial insert, size 2, 14mm Truliant CR Slope ++ tibial insert, size 1, 10mm Truliant PS tibial insert, size 4.5, 15mm Truliant PSC tibial insert, size 5, 10mm Truliant CR Slope ++ tibial insert, size 5, 10mm Truliant CR Neutral tibial insert, size 2, 12mm Truliant CR Slope + tibial insert, size 2.5, 10mm Truliant CRC tibial insert, size 5, 14mm Truliant PS tibial insert, size 5, 10mm Truliant CR Slope ++ tibial insert, size 3.5, 10mm Truliant PSC tibial insert, size 2.5, 14mm Truliant CRC tibial insert, size 5, 10mm Truliant PSC tibial insert, size 3, 12mm Truliant CR Neutral tibial insert, size 2.5, 10mm Truliant CR Neutral tibial insert, size 4.5, 11mm Truliant PS tibial insert, size 2.5, 14mm Truliant CR Slope + tibial insert, size 6, 12mm Truliant CR Neutral tibial insert, size 1.5, 14mm Truliant PS tibial insert, size 4, 14mm Truliant PSC tibial insert, size 1, 10mm Truliant PSC tibial insert, size 1, 12mm Truliant PS tibial insert, size 1.5, 12mm Truliant CRC tibial insert, size 4.5, 13mm Truliant CR Slope + tibial insert, size 4.5, 12mm Truliant PS tibial insert, size 4.5, 14mm Truliant PSC tibial insert, size 4.5, 17mm Truliant CR Neutral tibial insert, size 2.5, 14mm Truliant PS tibial insert, size 4.5, 11mm Truliant CR Slope ++ tibial insert, size 2, 10mm Truliant PSC tibial insert, size 4.5, 13mm Truliant PSC tibial insert, size 0, 14mm Truliant CR Slope + tibial insert, size 3, 12mm Truliant CRC tibial insert, size 3.5, 12mm Truliant PS tibial insert, size 1, 14mm Truliant PSC tibial insert, size 3, 10mm Truliant CR Slope + tibial insert, size 2.5, 12mm Truliant PS tibial insert, size 2.5, 10mm Truliant CR Neutral tibial insert, size 2.5, 12mm Truliant CRC tibial insert, size 4, 14mm Truliant CRC tibial insert, size 4.5, 10mm Truliant CRC tibial insert, size 1.5, 10mm Truliant CRC tibial insert, size 3, 14mm Truliant PS tibial insert, size 5, 12mm Truliant CR Neutral tibial insert, size 4.5, 15mm Truliant CR Neutral tibial insert, size 4.5, 17mm Truliant CR Neutral tibial insert, size 4, 10mm Truliant CRC tibial insert, size 1, 10mm Truliant PS tibial insert, size 1, 10mm Truliant PSC tibial insert, size 4, 12mm Truliant PS tibial insert, size 6, 14mm Truliant CR Neutral tibial insert, size 3, 14mm Truliant CR Neutral tibial insert, size 1, 10mm Truliant CR Neutral tibial insert, size 3, 10mm Truliant PSC tibial insert, size 5, 12mm Truliant CR Neutral tibial insert, size 4.5, 12mm Truliant Fit tibial tray, cemented, size 4.5F/3.5T Truliant CR Slope ++ tibial insert, size 3, 12mm Truliant CR Slope + tibial insert, size 3.5, 12mm Truliant PSC tibial insert, size 1, 14mm Truliant PS tibial insert, size 6, 10mm Truliant CR Slope ++ tibial insert, size 0, 12mm Truliant PS tibial insert, size 1, 12mm Truliant CR Neutral tibial insert, size 3, 12mm 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 4.5, 12mm Truliant CR Slope ++ tibial insert, size 4.5, 9mm Truliant PSC tibial insert, size 2, 14mm Truliant PS tibial insert, size 4.5, 13mm Truliant CR Slope ++ tibial insert, size 1, 12mm Truliant CRC tibial insert, size 4.5, 15mm Truliant CR Slope ++ tibial insert, size 6, 12mm Truliant CR Slope ++ tibial insert, size 1.5, 10mm Truliant PSC tibial insert, size 2.5, 10mm Truliant PS tibial insert, size 3, 12mm Truliant CR Slope + tibial insert, size 3, 10mm Truliant PSC tibial insert, size 4, 14mm Truliant PSC tibial insert, size 1.5, 10mm Truliant PS tibial insert, size 5, 14mm Truliant PS tibial insert, size 4.5, 17mm Truliant PS tibial insert, size 4, 12mm Truliant CRC tibial insert, size 6, 14mm Truliant PSC tibial insert, size 6, 12mm Truliant PSC tibial insert, size 1.5, 12mm Truliant PS tibial insert, size 4.5, 12mm Truliant PS tibial insert, size 4.5, 10mm Truliant CR Neutral tibial insert, size 3.5, 10mm Truliant CR Slope ++ tibial insert, size 2.5, 12mm Truliant CR Neutral tibial insert, size 5, 12mm Truliant CR Slope ++ tibial insert, size 3.5, 12mm Truliant CR Neutral tibial insert, size 6, 10mm Truliant CR Slope + tibial insert, size 0, 10mm Truliant CR Neutral tibial insert, size 2, 14mm Truliant PSC tibial insert, size 0, 12mm Truliant PSC tibial insert, size 4.5, 10mm Truliant CR Cemented Femoral, size 4.5 Right Truliant CR Slope ++ tibial insert, size 4.5, 13mm Truliant PS tibial insert, size 1.5, 10mm Truliant CRC tibial insert, size 1, 14mm Truliant CRC tibial insert, size 1, 12mm Truliant PSC tibial insert, size 1.5, 14mm Truliant CR Neutral tibial insert, size 6, 12mm Truliant PS tibial insert, size 2, 10mm Truliant PS tibial insert, size 3.5, 10mm Exactech Optetrak Logic CC Knee System BIT Optetrak Total Knee Sz 0/1 Delta Exactech Equinoxe Shoulder System Optetrak Logic Equinoxe Humeral Reconstruction Prosthesis

    Establishment Types

    Manufacture Medical Device