BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioScrew Xtralok

    Reg #: 1018470 · FEI: 1018470 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1018470
    FEI Number
    1018470
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2971 Olympic Industrial Dr SE Ste 116
    City
    Atlanta
    State
    GA
    ZIP
    30339
    Country
    US

    Regulatory Submissions

    510(k) Number
    K013131

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC

    Proprietary Names

    BioScrew Xtralok BIOSCREW XTRALOK 11MM X 35MM - VIOLET BIOABSORBABLE INTERFERENCE SCREW, VIOLET BIOSCREW XTRALOK 9MM X 35MM - VIOLET BIOABSORBABLE INTERFERENCE SCREW, VIOLET BIOSCREW XTRALOK 11MM X 40MM - VIOLET, BIOABSORBABLE INTERFERENCE SCREW, VIOLET BIOSCREW XTRALOK 9MM X 40MM - VIOLET, BIOABSORBABLE INTERFERENCE SCREW, VIOLET BIOSCREW XTRALOK 10MM X 35MM - VIOLET BIOABSORBABLE INTERFERENCE SCREW, VIOLET BIOSCREW XTRALOK 10MM X 40MM - VIOLET, BIOABSORBABLE INTERFERENCE SCREW, VIOLET

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)