BEUDAMED
    FDA Registration Active 🇺🇸 United States

    6 MM X 20 MM BIOSURE HA

    Reg #: 1219602 · FEI: 1219602 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMITH & NEPHEW INC.
    Registration Number
    1219602
    FEI Number
    1219602
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ENDOSCOPY, 120 FORBES BLVD. SUITE 150 / 130 FORBES BLVD.
    City
    MANSFIELD
    State
    MA
    ZIP
    02048
    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