BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Osteo-Wedge II Open Wedgge bone Locking Plate System

    Reg #: 3004993707 · FEI: 3004993707 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Graham Medical Technologies, L.L.C. d.b.a. GraMedica
    Registration Number
    3004993707
    FEI Number
    3004993707
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    16137 Leone Drive
    City
    Macomb
    State
    MI
    ZIP
    48042
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162179

    Owner / Operator

    Firm Name
    GRAMEDICA
    Operator Number
    9069880
    Address
    16137 Leone Drive, --
    City
    Macomb
    State
    MI
    Postal Code
    48042
    Country
    US

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS

    Proprietary Names

    Osteo-Wedge II Open Wedgge bone Locking Plate System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device