BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SternaFuse Fixation System

    Reg #: 3019923333 · FEI: 3019923333 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    FUSION INNOVATIONS
    Registration Number
    3019923333
    FEI Number
    3019923333
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    341 N. Maitland Ave, #270
    City
    Maitland
    State
    FL
    ZIP
    32751
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202914

    Owner / Operator

    Firm Name
    Fusion Innovations
    Operator Number
    10085560
    Address
    341 N. Maitland Ave, #270
    City
    Maitland
    State
    FL
    Postal Code
    32751
    Country
    US
    Correspondent
    Mark Schumacher

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    SternaFuse Fixation System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility