BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Premia (CH1) - ProMIS Fixation System

    Reg #: 1319660 · FEI: 1000136478 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    1319660
    FEI Number
    1000136478
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    23 ELIZABETH DR.
    City
    CHESTER
    State
    NY
    ZIP
    10918
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170061

    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
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    Premia (CH1) - ProMIS Fixation System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)