BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SCREW BIOSURE REGENESORB 9MM X 35MM

    Reg #: 3003604053 · FEI: 3003604053 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMITH & NEPHEW INC.
    Registration Number
    3003604053
    FEI Number
    3003604053
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ENDOSCOPY, 150 Minuteman Rd
    City
    ANDOVER
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142948

    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
    Fastener, Fixation, Biodegradable, Soft Tissue MAI

    Proprietary Names

    SCREW BIOSURE REGENESORB 9MM X 35MM SCREW BIOSURE REGENESORB 12MM X 35MM SCREW BIOSURE REGENESORB 9MM X 30MM BIOSURE REGENESORB SCREW BIOSURE REGENESORB 8MM X 25MM SCREW BIOSURE REGENESORB 10MM X 25MM SCREW BIOSURE REGENESORB 7MM X 25MM SCREW BIOSURE REGENESORB 10MM X 20MM SCREW BIOSURE REGENESORB 6MM X 25MM RT SCREW BIOSURE REGENESORB 8MM X 35MM SCREW BIOSURE REGENESORB 10MM X 35MM SCREW BIOSURE REGENESORB 8MM X 20MM SCREW BIOSURE REGENESORB 6MM X 20MM SCREW BIOSURE REGENESORB 7MM X 30MM SCREW BIOSURE REGENESORB 8MM X 30MM SCREW BIOSURE REGENESORB 10MM X 30MM SCREW BIOSURE REGENESORB 5MM X 25MM BIOSURE REGEN SCREW 5 X 20MM SCREW BIOSURE REGENESORB 9MM X 20MM SCREW BIOSURE REGENESORB 7MM X 20MM SCREW BIOSURE REGENESORB 8MM X 25MM RT SCREW BIOSURE REGENESORB 7MM X 25MM RT SCREW BIOSURE REGENESORB 11MM X 25MM SCREW BIOSURE REGENESORB 9MM X 25MM SCREW BIOSURE REGENESORB 11MM X 30MM SCREW BIOSURE REGENESORB 6MM X 25MM BIOSURE DRIVER 5MM SCREW BIOSURE REGENESORB 11MM X 35MM

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility