BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Syringe Plunger Red O-Ring

    Reg #: 3009973336 · FEI: 3009973336 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    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
    K141217

    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

    Syringe Plunger Red O-Ring 8mm PL Trial Graft Insertion Cannula Insertion Handle End Cap Instrument Tray Base Graft Insertion Pusher Prep Block Syringe Plunger PL Insertion Handle TL Tubing Set (STERILE) TL Instrument Set (Long Trial Handles) PL Insertion Handle Inner Shaft 6mm PL Trial 8mm TL Trial PL Instrument Set (Short Trial Handles) 10mm PL Trial TL Insertion Handle Instrument Tray Insert 6mm TL Trial TL Instrument Set (Short Trial Handles) Syringe Body Green O-Ring Insertion Handle Rotator Knob Syringe Body Instrument Tray Lid PL Tubing Set (STERILE) 10mm TL Trial TL Insertion Handle Inner Shaft Slap Hammer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)