BEUDAMED
    FDA Registration Active 🇺🇸 United States

    REDAPT FULLY POROUS SHELL 66MM

    Reg #: 1018470 · FEI: 1018470 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    4

    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
    K150790

    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
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    REDAPT FULLY POROUS SHELL 66MM REDAPT FULLY POROUS SHELL 76MM REDAPT FULLY POROUS SHELL 52MM REDAPT LOCKING SCREW 30MM REDAPT FULLY POROUS SHELL 72MM REDAPT LOCKING SCREW 35MM REDAPT FULLY POROUS SHELL 80MM REDAPT LOCKING SCREW 25MM REDAPT FULLY POROUS SHELL 78MM REDAPT FULLY POROUS SHELL 54MM REDAPT FULLY POROUS SHELL 62MM REDAPT FULLY POROUS SHELL 74MM REDAPT FULLY POROUS SHELL 58MM REDAPT LOCKING SCREW 15MM REDAPT LOCKING SCREW 60MM REDAPT FULLY POROUS SHELL 48MM REDAPT LOCKING SCREW 50MM REDAPT LOCKING SCREW 45MM REDAPT FULLY POROUS SHELL 70MM REDAPT LOCKING SCREW 70MM REDAPT FULLY POROUS SHELL 64MM REDAPT FULLY POROUS SHELL 68MM REDAPT FULLY POROUS SHELL 56MM REDAPT LOCKING SCREW 40MM REDAPT LOCKING SCREW 20MM REDAPT FULLY POROUS SHELL 50MM REDAPT FULLY POROUS SHELL 60MM REDAPT

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)