BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FEMORAL REVISION CEMENTED STD+ LEFT

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    99
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US, LLC
    Registration Number
    1526534
    FEI Number
    1526534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    305 Enterprise Dr
    City
    Lewis Center
    State
    OH
    ZIP
    43035
    Country
    US

    Regulatory Submissions

    PMA Number
    P830055

    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, Metal/Polymer, Mobile Bearing NJL

    Proprietary Names

    FEMORAL REVISION CEMENTED STD+ LEFT PRIMARY FEMORAL LG+ LRG+ LEFT POROCOAT® TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTED 3 TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTLESS 6 TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTLESS 3 TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTED 7 PRIMARY FEMORAL SM+ SML+ RIGHT CEMENTED FEMORAL REVISION CEMENTED LG+ LEFT PRIMARY FEMORAL MED MED RIGHT POROCOAT® PRIMARY FEMORAL STD+ STD+ LEFT POROCOAT® PRIMARY FEMORAL LG LRG RIGHT CEMENTED PRIMARY FEMORAL STD+ STD+ RIGHT POROCOAT® TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTLESS 1.5 TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTED 5 FEMORAL REVISION CEMENTED STD RIGHT PRIMARY FEMORAL STD STD RIGHT POROCOAT® TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTED 2 TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTLESS 1 PRIMARY FEMORAL STD STD LEFT CEMENTED TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTLESS 7 PRIMARY FEMORAL LG+ LRG+ RIGHT CEMENTED TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTED 2.5 PRIMARY FEMORAL STD+ STD+ RIGHT CEMENTED FEMORAL REVISION CEMENTED STD LEFT TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTED 3 FEMORAL REVISION CEMENTED LG LEFT TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTLESS 2.5 TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTLESS 1 FEMORAL REVISION CEMENTED SM+ RIGHT TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTED 1.5 TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTED 5 FEMORAL REVISION CEMENTED LG+ RIGHT PRIMARY FEMORAL SM+ SML+ RIGHT POROCOAT® TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTLESS 1.5 TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTED 1.5 FEMORAL REVISION CEMENTED MED LEFT PRIMARY FEMORAL STD STD RIGHT CEMENTED FEMORAL REVISION CEMENTED STD+ RIGHT TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTLESS 3 TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTLESS 2 PRIMARY FEMORAL LG LRG RIGHT POROCOAT® PRIMARY FEMORAL SM SML RIGHT CEMENTED PRIMARY FEMORAL STD STD LEFT POROCOAT® FEMORAL REVISION CEMENTED MED RIGHT PRIMARY FEMORAL SM+ SML+ LEFT POROCOAT® FEMORAL REVISION CEMENTED SM+ LEFT FEMORAL REVISION CEMENTED SM RIGHT TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTED 1 PRIMARY FEMORAL MED MED RIGHT CEMENTED TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTED 4 FEMORAL REVISION CEMENTED LG RIGHT TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTLESS 4 FEMORAL REVISION CEMENTED SM LEFT PRIMARY FEMORAL LG LRG LEFT CEMENTED ATTUNE SOLO PRIMARY CUT SIZE PRIMARY FEMORAL SM+ SML+ LEFT CEMENTED PRIMARY FEMORAL MED MED LEFT POROCOAT® PRIMARY FEMORAL MED MED LEFT CEMENTED TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTLESS 5 PRIMARY FEMORAL LG LRG LEFT POROCOAT® TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTED 6 PRIMARY FEMORAL SM SML LEFT POROCOAT® TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTED 4 TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTLESS 5 TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTED 6 TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTLESS 2.5 TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTLESS 7 PRIMARY FEMORAL SM SML LEFT CEMENTED TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTED 2 PRIMARY FEMORAL LG+ LRG+ LEFT CEMENTED TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTED 2.5 TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTLESS 2 PRIMARY FEMORAL SM SML RIGHT POROCOAT® TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTED 7 TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTLESS 4 TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE CEMENTED 1 TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE CEMENTLESS 6 PRIMARY FEMORAL LG+ LRG+ RIGHT POROCOAT® MBT REV TIB TRAY LCS CMP/SIGMA REV FEM SLV MBT TRAY SLEEVE LCS MENIS BEARING ATTUNE SOLO FEM FINISH PS LCS COM POST AUG MBT REVISION CEM TIB TRAY LCS COM DSTL AUG MBT STEP WEDGE UNIVERSAL FEM SLV LCS RP BRG LCS M BRDG BRG ATTUNE TIB SLV LCS COMPLETE REV FEM CEM LCS ROT PLAT BRNG LCS R BRDG BRG ATTUNE INTUITION SOLO PINNING ATTUNE EPAK PINNING SYSTEM PRIMARY FEMORAL STD+ STD+ LEFT CEMENTED ATTUNE SOLO SIZING ONLY PACK ATTUNE SOLO PATELLA PREP PACK

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)