BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IsoTis® Facet Fusion Instruments

    Reg #: 2090010 · FEI: 3001503333 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ISOTIS ORTHOBIOLOGICS, INC
    Registration Number
    2090010
    FEI Number
    3001503333
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Goodyear
    City
    IRVINE
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243659

    Owner / Operator

    Firm Name
    SeaSpine Orthopedics Corporation
    Operator Number
    10049589
    Address
    5770 Armada Dr
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    IsoTis® Facet Fusion Instruments FLASH™ Facet Fusion Instruments

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device