BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Humeral Nail, 7mm x 20cm

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029275
    FEI Number
    1000306431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    344 Bonnie Cir
    City
    Corona
    State
    CA
    ZIP
    92878
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050241

    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
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    Humeral Nail, 7mm x 20cm Cancellous Screw, Fully Threaded, 5mm x 45mm Humeral Nail, 7mm x 32.5cm Humeral Nail, 7mm x 27.5cm End Cap, 2mm Proximal Humeral Nail, 8mm x 15cm Humeral Nail, 9mm x 32.5cm Humeral Nail, 9mm x 25cm End Cap, 5mm Cortical Screw, 3.5mm x 30mm Fracture Redution Screw Cancellous Screw, Fully Threaded, 5mm x 55mm Cortical Screw, 3.5mm x 17.5mm Cortical Screw, 3.5mm x 32.5mm Humeral Nail, 7mm x 22.5cm Cancellous Screw, Fully Threaded, 5mm x 30mm Humeral Nail, 8mm x 25cm Humeral Nail, 9mm x 22.5cm Cortical Screw, 3.5mm x 25mm Cancellous Screw, Fully Threaded, 5mm x 25mm Humeral Nail, 9mm x 20cm Cancellous Screw, Fully Threaded, 5mm x 50mm Cortical Screw, 3.5mm x 40mm Cortical Screw, 3.5mm x 27.5mm Humeral Nail, 8mm x 20cm Humeral Nail, 8mm x 27.5cm Cancellous Screw, Fully Threaded, 5mm x 35mm Cortical Screw, 3.5mm x 37.5mm Humeral Nail, 8mm x 22.5cm Cancellous Screw, Fully Threaded, 5mm x 60mm Cortical Screw, 3.5mm x 35mm Humeral Nail, 8mm x 32.5cm Cortical Screw, 3.5mm x 22.5mm Humeral Nail, 7mm x 30cm Humeral Nail, 8mm x 30cm Cancellous Screw, Fully Threaded, 5mm x 40mm Humeral Nail, 9mm x 27.5cm Cortical Screw, 3.5mm x 20mm Humeral Nail, 9mm x 30cm Humeral Nail, 7mm x 25cm

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)