BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PERI-LOC

    Reg #: 8010764 · FEI: 3002465897 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    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
    K061352

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    PERI-LOC

    Establishment Types

    Manufacture Medical Device