BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PolyLock Plating System

    Reg #: 3013365802 · FEI: 3013365802 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    FUSION ORTHOPEDICS USA, LLC
    Registration Number
    3013365802
    FEI Number
    3013365802
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6859 E Rembrandt Ave, Ste 122
    City
    Mesa
    State
    AZ
    ZIP
    85212
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211843

    Owner / Operator

    Firm Name
    Fusion Orthopedics, LLC.
    Operator Number
    10053147
    Address
    4135 S Power Rd., Suite 110
    City
    Mesa
    State
    AZ
    Postal Code
    85212
    Country
    US
    Correspondent
    Adam Cundiff

    Products

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

    Proprietary Names

    PolyLock Plating System

    Establishment Types

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