BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Appliance, Fixation, Spinal Interl

    Reg #: 3009973336 · FEI: 3009973336 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    5

    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
    K132014

    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
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    Appliance, Fixation, Spinal Interl Orthosis, spondylolisthesis spinal fixation Appliance, Fixation, Spinal Intervertebral Body Orthosis, Spinal Pedicle Fixation Orthosis, spinal pedicle fixation, for degenerative disc disease

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)