BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    BIOLOX

    Reg #: 8010764 · FEI: 3002465897 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    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
    K100412

    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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    BIOLOX DELTA

    Establishment Types

    Manufacture Medical Device