BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TOTAL KNEE SYSTEM INSTRUMENTATION

    Reg #: 3009973336 · FEI: 3009973336 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    8

    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
    K121393

    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
    Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer KRQ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO

    Proprietary Names

    TOTAL KNEE SYSTEM INSTRUMENTATION

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)