BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIMPEX MEDICAL, INC.

    Reg #: 3025266 · FEI: 1000126034 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SIMPEX MEDICAL, INC.
    Registration Number
    3025266
    FEI Number
    1000126034
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1974 Carolina Place Drive, Suite 216-A
    City
    Fort Mill
    State
    SC
    ZIP
    29708
    Country
    US

    Regulatory Submissions

    510(k) Number
    K911505

    Owner / Operator

    Firm Name
    SIMPEX MEDICAL, INC.
    Operator Number
    9002476
    Address
    2780 Disney Place, --
    City
    Fort Mill
    State
    SC
    Postal Code
    29707
    Country
    US
    Correspondent
    RICHARD - GORSKI

    Products

    Device Name Product Code
    Bit, Drill HTW
    Pin, Fixation, Smooth HTY

    Proprietary Names

    Drill Bit Round Shank Drill Bit K-Wire Kirschner Wire Steinmann Pin

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility