BEUDAMED
    FDA Registration Active 🇺🇸 United States

    StabiliT MX Fracture Kit with PowerCURVE, Base, Long

    Reg #: 2953359 · FEI: 3000215205 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics U.S. LLC
    Registration Number
    2953359
    FEI Number
    3000215205
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2311 Lincoln Ave
    City
    Hayward
    State
    CA
    ZIP
    94545
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090986

    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
    Dispenser, Cement KIH
    Cement, Bone, Vertebroplasty NDN

    Proprietary Names

    StabiliT MX Fracture Kit with PowerCURVE, Base, Long StabiliT Second Fracture Kit with PowerCURVE, Short StabiliT Second Fracture Kit with PowerCURVE, Long StabiliT First Fracture Kit with PowerCURVE (Blister Pack), Short StabiliT MX Fracture Kit with PowerCURVE, Full, Short StabiliT Complete Fracture Kit with PowerCURVE, Short StabiliT First Fracture Kit (Blister Pack), Short StabiliT First Fracture Kit (Blister Pack), Long StabiliT First Fracture Kit with PowerCURVE, Long StabiliT MX Fracture Kit with PowerCURVE, Full, Long StabiliT Complete Fracture Kit with PowerCURVE, Long StabiliT Mx Fracture Kit with PowerCURVE, Base, Short

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)