BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SMF Stem Osteotomy Guide

    Reg #: 3009973336 · FEI: 3009973336 · Expires 2025
    View on FDA
    Products
    13
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    13

    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
    K123598

    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, Hip, Hemi-, Femoral, Metal Ball LZY
    Mesh, Surgical, Acetabular, Hip, Prosthesis JDJ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Cerclage, Fixation JDQ
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Proprietary Names

    SMF Stem Osteotomy Guide Peri-Loc

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)