BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GEO Bone Screw System

    Reg #: 3012478585 · FEI: 3012478585 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
    Registration Number
    3012478585
    FEI Number
    3012478585
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1239 N Glenville Dr
    City
    Richardson
    State
    TX
    ZIP
    75081
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161904

    Owner / Operator

    Firm Name
    Gramercy Extremity Orthopedics, LLC.
    Operator Number
    10053967
    Address
    1239 N. Glenville Drive
    City
    Richardson
    State
    TX
    Postal Code
    75081
    Country
    US
    Correspondent
    John Rigol

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Washer, Bolt Nut HTN

    Proprietary Names

    GEO Bone Screw System

    Establishment Types

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