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    FDA Registration Active 🇺🇸 United States

    NexxtSpine14118 (CH2) - NEXXT MATRIXX

    Reg #: 3013820501 · FEI: 3013820501 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Isomedix Operations Inc.
    Registration Number
    3013820501
    FEI Number
    3013820501
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Nucifora Blvd
    City
    Chester
    State
    NY
    ZIP
    10918
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193412

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    9072619
    Address
    5960 Heisley Road, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Spinal Vertebral Body Replacement Device MQP

    Proprietary Names

    NexxtSpine14118 (CH2) - NEXXT MATRIXX

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)