BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE

    Reg #: 3008421730 · FEI: 3008421730 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Lincotek Medical
    Registration Number
    3008421730
    FEI Number
    3008421730
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3110 Stage Post Dr Ste 117
    City
    Bartlett
    State
    TN
    ZIP
    38133
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051385

    Owner / Operator

    Firm Name
    Surface Dynamics LLC
    Operator Number
    10047928
    Address
    3110 Stage Post Dr Ste 101
    City
    Bartlett
    State
    TN
    Postal Code
    38133
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI

    Proprietary Names

    EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)