BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MIFix Cannulated Screw 3.5mm(793501-1022~1064)

    Reg #: 3031261833 · FEI: 3031261833 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TDM USA INC.
    Registration Number
    3031261833
    FEI Number
    3031261833
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4020 215th Street
    City
    Bayside
    State
    NY
    ZIP
    11361
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231860

    Owner / Operator

    Firm Name
    TDM USA INC.
    Operator Number
    10090919
    Address
    4020 215th Street
    City
    Bayside
    State
    NY
    Postal Code
    11361
    Country
    US
    Correspondent
    Minjeong Kim-Jin

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC

    Proprietary Names

    MIFix Cannulated Screw 3.5mm(793501-1022~1064) TDM Screw System 7.5mm Limited Sliding Locking Screw, Long(775101-2070~2110) MIFix Cannulated Screw 3mm(793001-1020~1050) 7.5mm Limited Sliding Locking Screw, Short(775001-2070~2110)

    Establishment Types

    Repack or Relabel Medical Device