BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PLUS VKS Rev TCRev Fem Comp. Rev RT VKS3

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    1

    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
    K032215

    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, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    PLUS VKS Rev TCRev Fem Comp. Rev RT VKS3 PLUS TC REV. 2DEG. VALGUS STEM SZ10-80MM PLUS TC REV. 2DEG. VALGUS STEM SZ14-80MM PLUS VKS Rev TCRev Fem Comp. Rev RT VKS2 PLUS TC REV. STRAIGHT STEM SZ 10-80MM PLUSTC REV. 2DEG. VALGUS STEM SZ12-110MM PLUS TC REV. STRAIGHT STEM SZ 20-150MM PLUS VKS Rev TC Rev Fem Block D.M RT 5 PLUS VKS Rev TC Rev Fem Block D.M RT10 PLUSTC REV. 2DEG. VALGUS STEM SZ14-150MM PLUS VKS Rev TC Rev Fem Block Post 10 mm PLUS TC REV. STRAIGHT STEM SZ 16-150MM PLUS VKS Rev TC Rev Fem Block D.M LT 10 PLUS VKS Rev TC Rev Fem Comp. Rev LT VKS PLUSTC REV. 2DEG. VALGUS STEM SZ14-110MM PLUS VKS Rev TC Rev Fem Block D.L 5 mm V PLUS TC REV. STRAIGHT STEM SZ 18-110MM PLUS TC REV. STRAIGHT STEM SZ 16-80MM PLUS TC REV. STRAIGHT STEM SZ 12-110MM PLUS TC REV. 2DEG. VALGUS STEM SZ16-80MM PLUS VKS Rev TCRev Fem Comp. Rev RT VKS4 PLUS TC REV. STRAIGHT STEM SZ 18-150MM PLUS TC REV. 2DEG. VALGUS STEM SZ12-80MM PLUS VKS Rev TC Rev Fem Block D.M LT 5 V PLUSTC REV. 2DEG. VALGUS STEM SZ16-150MM PLUS VKS Rev TC Rev Fem Blck D.L 10 mm V PLUSTC REV. 2DEG. VALGUS STEM SZ18-110MM PLUS TC REV. STRAIGHT STEM SZ 14-80MM PLUSTC REV. 2DEG. VALGUS STEM SZ18-150MM Stem non-cemented 16/110 mm PLUSTC REV. 2DEG. VALGUS STEM SZ10-110MM PLUS TC REV. STRAIGHT STEM SZ 14-150MM PLUS VKS Rev TCRev Fem Comp. Rev LT VKS5 PLUS TC REV. STRAIGHT STEM SZ 14-110MM PLUSTC REV. 2DEG. VALGUS STEM SZ20-150MM PLUSTC REV. 2DEG. VALGUS STEM SZ16-110MM PLUS TC REV. STRAIGHT STEM SZ 12-80MM

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)