BEUDAMED
    FDA Registration Active 🇺🇸 United States

    F³ FRAGMENT PLATING SYSTEMSMALL FRAG LOCKING PLATE

    Reg #: 3007993775 · FEI: 3007993775 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    Structure Medical, LLC.
    Registration Number
    3007993775
    FEI Number
    3007993775
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    111 Cayuga Dr.
    City
    Mooresville
    State
    NC
    ZIP
    28117
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111663

    Owner / Operator

    Firm Name
    Structure Medical, LLC.
    Operator Number
    10042434
    Address
    9935 Business Circle
    City
    Naples
    State
    FL
    Postal Code
    34112
    Country
    US
    Correspondent
    Tejash Naik

    Products

    Device Name Product Code
    Washer, Bolt Nut HTN
    Plate, Fixation, Bone HRS
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Pin, Fixation, Smooth HTY
    Rod, Fixation, Intramedullary And Accessories HSB
    Screw, Fixation, Bone HWC
    Pin, Fixation, Threaded JDW
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT

    Proprietary Names

    F³ FRAGMENT PLATING SYSTEMSMALL FRAG LOCKING PLATE DISTAL HUMERAL MEDIAL PLATE A.L.P.S. ELBOW SYSTEMDISTAL HUMERAL POSTERIOR LATERAL PLATE CORONOID PLATE PROXIMAL RADIUS PLATE OLECRANON PLATE DISTAL HUMERAL LATERAL PLATE A.L.P.S. ELBOW SYSTEM OLECRANON PLATE LOW PROFILE CORTICAL WASHER A.L.P.S. ELBOW SYSTEMDISTAL HUMERAL LATERAL PLATE A.L.P.S. ELBOW SYSTEM DISTAL HUMERAL MEDIAL PLATE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)