BEUDAMED
    FDA Registration Active 🇺🇸 United States

    REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 24 HIGH OFFSET

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    64
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3002907620
    FEI Number
    3002907620
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1700 College Blvd.
    City
    West Memphis
    State
    AR
    ZIP
    72301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162303

    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, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH

    Proprietary Names

    REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 24 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 20 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 15 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 19 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 25 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 12 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 23 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 12 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 21 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM -240mm SIZE 13 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 23 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 14 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 18 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 13 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 27 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 21 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 22 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 17 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 27 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM -240mm SIZE 14 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 16 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 26 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 16 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 23 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 18 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 18 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 17 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 27 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 13 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 17 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 14 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 23 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 21 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 16 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 21 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 26 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 19 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 20 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 25 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 14 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 16 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 22 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 24 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 25 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 13 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 20 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 15 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 26 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 24 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 20 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 15 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 22 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 12 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 18 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 25 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 19 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 22 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 24 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 17 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 15 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 26 STANDARD OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 27 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-240mm SIZE 19 HIGH OFFSET REDAPT SLEEVED MONOLITHIC REVISION STEM-300mm SIZE 12 HIGH OFFSET

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)