BEUDAMED
    FDA Registration Active 🇺🇸 United States

    8 X 25 MM BIORCI SCREW

    Reg #: 1219602 · FEI: 1219602 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    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
    K992396

    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

    8 X 25 MM BIORCI SCREW 8 X 30 MM BIORCI SCREW 9 X 35 MM BIORCI SCREW L SCREW STARTER 9 X 25 MM BIORCI SCREW 7 MM X 25 MM REVERSE THREAD BIORCI SCREW 8 X 35 MM BIORCI SCREW 7 X 25 MM BIORCI SCREW 9 X 30 MM BIORCI SCREW 7 X 25 MM BIORCI SCREW WITH AN 8 MM HEAD 10 X 30 MM BIORCI SCREW 7 X 30 MM BIORCI SCREW BIORCI SCREW, Sterile

    Establishment Types

    Manufacture Medical Device