BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Smith&Nephew3754 (NR) - EndoButton Direct Fixation Device, 9mm

    Reg #: 1220477 · FEI: 1220477 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    1220477
    FEI Number
    1220477
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    435 WHITNEY ST.
    City
    Northboro
    State
    MA
    ZIP
    01532
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070167

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    Smith&Nephew3754 (NR) - EndoButton Direct Fixation Device, 9mm Smith&Nephew3754 (NR) - EndoButton Direct Fixation Device, 5mm Smith&Nephew3754 (NR) EndoButton Direct Fixation Device, 8mm Smith&Nephew3754 (NR) - EndoButton Direct Fixation Device, 6mm Smith&Nephew3754 (NR) - EndoButton Direct Fixation Device, 7mm Smith&Nephew3754 (NR) - EndoButton Direct Fixation Device, 10mm

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)