BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Retrofix

    Reg #: 3017075357 · FEI: 3017075357 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RETROFIX SCREWS, LLC
    Registration Number
    3017075357
    FEI Number
    3017075357
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    710 Mitchell Ave
    City
    Salisbury
    State
    NC
    ZIP
    28144
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200226

    Owner / Operator

    Firm Name
    Retrofix Screws, LLC
    Operator Number
    10075980
    Address
    710 Mitchell Ave
    City
    Salisbury
    State
    NC
    Postal Code
    28144
    Country
    US
    Correspondent
    Keith Barritt

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC

    Proprietary Names

    Retrofix Depth Gauge Part No. CTM000887 Cannulated Screwdriver Part No. CTM000893 Upper Instrument Tray Part No. CTM001164 Caddie (Tray) Assembly Part No. AFNM000369 Lower instrument Tray Part No. CTM001165 K-wire 1.3 x 300 mm Part No. CTM001055 4.7 mm Drill Bit Part No. CTM000936 Caddie (Tray) Lid Part No. CTM001163 Drill guide -Tissue Protector Part No. CTM000886 4 mm Drill Bit Part No. CTM000884 K-wire 1.3 x 225 mm Part No. CTM000882

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility