BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Instrument Tray Lid

    Reg #: 3009973336 · FEI: 3009973336 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Engineered Medical Systems, LLC
    Registration Number
    3009973336
    FEI Number
    3009973336
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3325 Appling Rd
    City
    Bartlett
    State
    TN
    ZIP
    38133
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132505

    Owner / Operator

    Firm Name
    Engineered Medical Systems, LLC
    Operator Number
    10042524
    Address
    3325 Appling Road
    City
    Bartlett
    State
    TN
    Postal Code
    38133
    Country
    US
    Correspondent
    Dwayne Wisham

    Products

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

    Proprietary Names

    Instrument Tray Lid TL Insertion Handle Graft Insertion Cannula 8mm PL Trial Instrument Tray Base 6mm TL Trial PL Insertion Handle Inner Shaft TL Insertion Handle Inner Shaft 6mm PL Trial Insertion Handle End Cap 10mm TL Trial Instrument Tray Insert TL Instrument Set (Long Trial Handles) 8mm TL Trial 10mm PL Trial PL Instrument Set (Long Trial Handles) Prep Block Slap Hammer Graft Insertion Pusher PL Tubing Set (STERILE) TL Tubing Set (STERILE) PL Insertion Handle Insertion Handle Rotator Knob

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)