BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sypher ALIF Spacer System

    Reg #: 3008773560 · FEI: 3008773560 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOGENNIX, LLC
    Registration Number
    3008773560
    FEI Number
    3008773560
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18009 Sky Park Cir Ste K
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141798

    Owner / Operator

    Firm Name
    Biogennix, LLC
    Operator Number
    10030571
    Address
    18007 Sky Park Circle, Suite D
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Edwin C Shors

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    Sypher ALIF Spacer System

    Establishment Types

    Manufacture Medical Device