BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Acumed4864 (NT) - Ankle Plating System 3

    Reg #: 2032098 · FEI: 3003058448 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Isomedix Operations, Inc
    Registration Number
    2032098
    FEI Number
    3003058448
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1000 Sarah Pl
    City
    ONTARIO
    State
    CA
    ZIP
    91761
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143394

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    Acumed4864 (NT) - Ankle Plating System 3

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)