BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GENESIS BIOLOGICS, INC.

    Reg #: 3016948539 · FEI: 3008066433 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    GENESIS BIOLOGICS, INC.
    Registration Number
    3016948539
    FEI Number
    3008066433
    Status
    Active
    Expiry Year
    2026
    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
    Orthopedic Manual Surgical Instrument LXH
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Platelet And Plasma Separator For Bone Graft Handling ORG

    Proprietary Names

    Genesis Push-In Suture Anchor Genesis Screw-In Anchor Genesis Dual Thread Screw-In Anchor AlternatiV+ Screw-In Anchor Awl/Tapper Awl Dual Pitch AWL/Tapper Genesis Drill Bit Genesis Dual Pitch AWL/Tapper Genesis Drill Guide Drill Bit Genesis Awl/Tapper Genesis Awl Drill Guide AlternatiV+ Max Knotless Anchor Genesis Knotless Anchor Genesis All Suture Anchor Genesis PRP Adaptive Autologous Processing System

    Establishment Types

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