BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EVOS DISTAL RADIUS VOLAR PLATE 4H WIDE 56MM

    Reg #: 8010764 · FEI: 3002465897 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    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
    K181533

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    EVOS DISTAL RADIUS VOLAR PLATE 4H WIDE 56MM EVOS DISTAL RADIUS VOLAR PLATE 7H WIDE TITANIUM 105MM EVOS DISTAL RADIUS VOLAR PLATE 5H STANDARD 76MM EVOS EVOS DISTAL RADIUS VOLAR PLATE 7H WIDE 100MM EVOS DISTAL RADIUS VOLAR PLATE 5H STANDARD TITANIUM 81MM EVOS TITANIUM 3.5MM X 10MM CORTEX SCREW T15 SELF-TAPPING EVOS TITANIUM 1.8MM X 10MM LOCKING PEG T7 EVOS DISTAL RADIUS VOLAR PLATE 10H RIGHT STANDARD 138MM EVOS DISTAL RADIUS VOLAR PLATE 5H WIDE TITANIUM 83MM EVOS RADIAL SHAFT PLATE 8H 98MM EVOS DISTAL RADIUS VOLAR PLATE 3H WIDE TITANIUM 48MM EVOS 1.8MM X 10MM LOCKING PEG T7 EVOS DISTAL RADIUS VOLAR PLATE 7H STANDARD TITANIUM 105MM EVOS DISTAL RADIUS VOLAR PLATE 4H STANDARD 56MM EVOS DISTAL RADIUS VOLAR PLATE 4H STANDARD TITANIUM 56MM EVOS DISTAL ULNA PLATE 7H TITANIUM 34MM EVOS PROXIMAL RADIAL SHAFT PLATE 5H L 95MM EVOS TITANIUM 3.5MM X 10MM LOCKING SCREW T15 SELF TAPPING EVOS DISTAL RADIUS RADIAL COLUMN PLATE 4H TITANIUM 57MM EVOS DISTAL RADIUS DORSAL PLATE 3H STANDARD TITANIUM 56MM EVOS DISTAL RADIUS VOLAR PLATE 7H STANDARD 100MM EVOS DISTAL RADIUS VOLAR PLATE 5H WIDE 78MM EVOS DISTAL RADIUS DORSAL PLATE 3H WIDE TITANIUM 58MM EVOS DISTAL RADIUS VOLAR PLATE 4H WIDE TITANIUM 56MM EVOS DISTAL RADIUS VOLAR PLATE 3H STANDARD TITANIUM 48MM EVOS DISTAL RADIUS VOLAR PLATE 3H STANDARD 48MM EVOS DISTAL RADIUS VOLAR PLATE 3H WIDE 48MM EVOS DISTAL RADIUS INTERMEDIATE COLUMN PLATE 4H TITANIUM 54MM EVOS DISTAL RADIUS VOLAR PLATE 10H STANDARD TITANIUM 141MM

    Establishment Types

    Manufacture Medical Device