BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KeyLift Expandable Interlaminar Fusion System 10mm Rasp Trial (07-7000-010)

    Reg #: 3009888740 · FEI: 3009888740 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Orchid Orthopedic Solutions Alabama LLC
    Registration Number
    3009888740
    FEI Number
    3009888740
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    331 City Park Dr SE
    City
    Arab
    State
    AL
    ZIP
    35016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232484

    Owner / Operator

    Firm Name
    Orchid Orhopedics
    Operator Number
    10042268
    Address
    331 City Park Dr. SE
    City
    Arab
    State
    AL
    Postal Code
    35016
    Country
    US
    Correspondent
    Joel Roth

    Products

    Device Name Product Code
    Spinous Process Plate PEK

    Proprietary Names

    KeyLift Expandable Interlaminar Fusion System 10mm Rasp Trial (07-7000-010) KeyLift Expandable Interlaminar Fusion System Inserter (07-7000-016) KeyLift Expandable Interlaminar Fusion System 8mm Rasp Trial (07-7000-008) KeyLift Expandable Interlaminar Fusion System 12mm Rasp Trial (07-7000-012) KeyLift Expandable Interlaminar Fusion System 6mm Rasp Trial (07-7000-006)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)