BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Plate, Fixation, Bone (Total Foot System, GEN II)

    Reg #: 1828288 · FEI: 1828288 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ORCHID UNIQUE
    Registration Number
    1828288
    FEI Number
    1828288
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6688 Dixie Hwy
    City
    Bridgeport
    State
    MI
    ZIP
    48722
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123000

    Owner / Operator

    Firm Name
    Unique Instruments Inc.
    Operator Number
    10042005
    Address
    6688 Dixie Hwy
    City
    Bridgeport
    State
    MI
    Postal Code
    48722
    Country
    US

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    Plate, Fixation, Bone (Total Foot System, GEN II) 2.7MM Drill Bit W/AO (magenta) 1.8 MM Drill Bit W/AO (Blue) 2.5 MM hex driver, Non-Cannulated W/AO Olive Wires 100 X 1.1MM 3.9 MM Snap on Drill guide , 45 MM (purple) Drill Bit, 3.5 MM W/AO(purple) 2.5 MM snap on Drill guide, 45 MM (yellow) 1.5 MM Drill Bit W/AO (lt. Green) Drill Bit, 2.5 MM, W/AO (yellow) TX 8 Driver, Non-Cannulated W/AO 1.8 MM Snap on Drill Guide (blue) 1.8 MM Compression Drill Guide (Blue) 2.7 MM Snap on Drill Guide (magenta)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)