BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SpineWave3277 (NR,WH) - StaXx XD TI

    Reg #: 2245304 · FEI: 2245304 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    2245304
    FEI Number
    2245304
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Apollo Dr
    City
    WHIPPANY
    State
    NJ
    ZIP
    07981
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142996

    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
    Spinal Vertebral Body Replacement Device MQP

    Proprietary Names

    SpineWave3277 (NR,WH) - StaXx XD TI

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)