BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tibial Nail, 11mm x 31.5cm

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    75
    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
    K070444

    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

    Tibial Nail, 11mm x 31.5cm Tibial Nail, 9mm x 31.5cm Cannualted Cancellous Screw, Partially Threaded, 5mm x 70mm Captured Cortical Screw, 4.2mm x 30mm Tibial Nail, 10mm x 37.5cm Tibial Nail, 11mm x 30cm Tibial Nail, 11mm x 27cm Tibial Nail, 9mm x 33cm Tibial Nail, 11mm x 28.5cm Tibial Nail, 8mm x 39cm Spacer Captured Cortical Screw, 5mm x 46mm Captured Cortical Screw, 5mm x 34mm Tibial Nail, 9mm x 34.5cm Captured Cortical Screw, 5mm x 42mm Tibial Nail, 8mm x 34.5cm Captured Cortical Screw, 4.2mm x 25mm Tibial Nail, 9mm x 27cm Cannualted Cancellous Screw, Partially Threaded, 5mm x 80mm Tibial Nail, 9mm x 28.5cm Tibial Nail, 8mm x 37.5cm Tibial Nail, 10mm x 28.5cm Tibial Nail, 8mm x 27cm Captured Cortical Screw, 5mm x 28mm Captured Cortical Screw, 5mm x 80mm Captured Cortical Screw, 5mm x 75mm Tibial Nail, 8mm x 36cm Captured Cortical Screw, 5mm x 30mm Tibial Nail, 11mm x 39cm Captured Cortical Screw, 5mm x 65mm Cannualted Cancellous Screw, Partially Threaded, 5mm x 60mm End Cap, 5mm Captured Cortical Screw, 5mm x 44mm Cannualted Cancellous Screw, Partially Threaded, 5mm x 55mm Tibial Nail, 11mm x 33cm Cannualted Cancellous Screw, Partially Threaded, 5mm x 65mm Tibial Nail, 8mm x 31.5cm Captured Cortical Screw, 5mm x 36mm Tibial Nail, 8mm x 28.5cm Captured Cortical Screw, 4.2mm x 40mm Cannualted Cancellous Screw, Partially Threaded, 5mm x 75mm Tibial Nail, 10mm x 36cm End Cap, Compression Captured Cortical Screw, 5mm x 40mm Tibial Nail, 10mm x 39cm Cannualted Cancellous Screw, Partially Threaded, 5mm x 40mm Tibial Nail, 10mm x 33cm Captured Cortical Screw, 4.2mm x 45mm Tibial Nail, 11mm x 34.5cm Tibial Nail, 8mm x 33cm Captured Cortical Screw, 5mm x 50mm Captured Cortical Screw, 5mm x 70mm Captured Cortical Screw, 5mm x 24mm Captured Cortical Screw, 5mm x 55mm Tibial Nail, 10mm x 27cm End Cap, 10mm Tibial Nail, 9mm x 30cm Tibial Nail, 10mm x 31.5cm Tibial Nail, 10mm x 34.5cm Tibial Nail, 10mm x 30cm Captured Cortical Screw, 5mm x 48mm Captured Cortical Screw, 5mm x 26mm Tibial Nail, 9mm x 39cm Cannualted Cancellous Screw, Partially Threaded, 5mm x 45mm Cannualted Cancellous Screw, Partially Threaded, 5mm x 50mm Captured Cortical Screw, 4.2mm x 50mm Tibial Nail, 11mm x 36cm Tibial Nail, 11mm x 37.5cm Captured Cortical Screw, 5mm x 60mm Tibial Nail, 9mm x 37.5cm Tibial Nail, 8mm x 30cm Captured Cortical Screw, 5mm x 38mm Captured Cortical Screw, 4.2mm x 35mm Tibial Nail, 9mm x 36cm Captured Cortical Screw, 5mm x 32mm

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)