BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Genesis Screw-In Anchor

    Reg #: 3016948539 · FEI: 3008066433 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GENESIS BIOLOGICS, INC.
    Registration Number
    3016948539
    FEI Number
    3008066433
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    17791 Mitchell North, Suite D
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230892

    Owner / Operator

    Firm Name
    Genesis Biologics, Inc.
    Operator Number
    10074842
    Address
    17791 Mitchell North, Suite D
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Steven Bee

    Products

    Device Name Product Code
    Fastener, Fixation, Biodegradable, Soft Tissue MAI

    Proprietary Names

    Genesis Screw-In Anchor Genesis Dual Thread Screw-In Anchor Genesis Push-In Suture Anchor AlternatiV+ Screw-In Anchor

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198