BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    HARMONY

    Reg #: 8010764 · FEI: 3002465897 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    SMITH & NEPHEW ORTHOPAEDICS, GMBH
    Registration Number
    8010764
    FEI Number
    3002465897
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ALEMANNENSTRASSE 14
    City
    TUTTLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K121393

    Owner / Operator

    Firm Name
    Smith & Nephew, Inc.
    Operator Number
    1020279
    Address
    2875 Railroad Street
    City
    Pittsburgh
    State
    PA
    Postal Code
    15222
    Country
    US
    Correspondent
    Lisa Ewing

    US Agent

    Business Name
    SMITH & NEPHEW, INC.
    Contact Name
    Lisa Ewing
    Address
    2875 Railroad St
    City
    Pittsburgh
    State
    PA
    ZIP
    15222
    Country
    US
    Email
    [email protected]
    Phone
    412 4199765

    Products

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

    Proprietary Names

    HARMONY GENESIS LEGION JOURNEY PROFIX SYNC

    Establishment Types

    Manufacture Medical Device