BEUDAMED
    FDA Registration Active 🇺🇸 United States

    6 MM X 20 MM BIOSURE HA

    Reg #: 1643264 · FEI: 1643264 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMITH & NEPHEW INC.
    Registration Number
    1643264
    FEI Number
    1643264
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    ENDOSCOPY, 76 S. MERIDIAN AVE.
    City
    OKLAHOMA CITY
    State
    OK
    ZIP
    73107
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080358

    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

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC

    Proprietary Names

    6 MM X 20 MM BIOSURE HA 9 MM X 35 MM BIOSURE HA 8 MM X 25 MM BIOSURE HA REVERSE THREAT 8 MM X 35MM BIOSURE HA 9 MM X 20 MM BIOSURE HA 7 MM X 30 MM BIOSURE HA FLEXIBLE TAP BIOSURE 7MM 10 MM X 30 MM BIOSURE HA 9 MM X 30 MM BIOSURE HA 8 MM X 20 MM BIOSURE HA 11 MM X 30 MM BIOSURE HA 7 MM X 20 MM BIOSURE HA 6 MM X 25 MM BIOSURE HA 6 MM X 25 MM BIOSURE HA REVERSE THREAD 7 MM X 25 MM BIOSURE HA 10 MM X 20 MM BIOSURE HA FLEXIBLE TAP BIOSURE 6MM 10 MM X 35 MM BIOSURE HA 9 MM X 25 MM BIOSURE HA 8 MM X 25 MM BIOSURE HA 8 MM X 30MM BIOSURE HA 12 MM X 35 MM BIOSURE HA 11 MM X 25 MM BIOSURE HA FLEXIBLE DRIVER BIOSURE FLEXIBLE TAP BIOSURE 8MM FLEXIBLE TAP BIOSURE 10MM 7 MM X 25 MM BIOSURE HA REVERSE THREAD 11 MM X 35 MM BIOSURE HA FLEXIBLE TAP BIOSURE 9MM 10 MM X 25 MM BIOSURE HA PLLA, HA SCREW

    Establishment Types

    Manufacture Medical Device