BEUDAMED
    FDA Registration Active 🇺🇸 United States

    REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 26 HI OFFSET

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    96
    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
    K151902

    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 SLVLS MONOLITHIC REV STEM 300MM SZ 26 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 22 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 22 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 21 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 23 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 13 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 12 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 19 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 18 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 22 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 17 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 23 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 27 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 27 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 14 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 25 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 18 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 13 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 27 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 24 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 15 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 25 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 19 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 13 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 22 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 20 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 27 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 15 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 13 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 17 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 23 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 27 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 18 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 15 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 15 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 20 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 19 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 16 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 14 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 22 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 26 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 12 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 24 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 16 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 17 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 25 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 12 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 24 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 12 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 16 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 18 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 20 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 14 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 19 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 26 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 18 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 23 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 21 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 20 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 21 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 26 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 17 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 27 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 19 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 25 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 21 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 17 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 18 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 19 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 12 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 20 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 13 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 21 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 16 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 21 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 24 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 15 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 26 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 22 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 14 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 23 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 12 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 25 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 20 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 16 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 24 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 16 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 26 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 25 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 17 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 190MM SZ 23 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 14 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 24 HI OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 14 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 300MM SZ 13 STD OFFSET REDAPT SLVLS MONOLITHIC REV STEM 240MM SZ 15 STD OFFSET

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)