BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 11 HI 117mm

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    43
    Establishment Types
    1
    Classifications
    2

    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

    510(k) Number
    K073570

    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, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 11 HI 117mm FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 12.5mm LAT FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 10 HI 115mm FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 15mm STD FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 12 HI 119mm FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 13.8mm STD FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 11.3mm STD FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 17.5mm LAT FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 11.3mm LAT FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 6 STD 107mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 12 STD 119mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 0 HI 95mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 8 STD 111mm FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 7.5mm LAT FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 2 STD 99mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 1 HI 97mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 5 HI 105mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 3 HI 101mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 2 HI 99mm FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 8.8mm LAT FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 10mm STD FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 6.3mm STD FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 9 HI 113mm FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 12.5mm STD FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 9 STD 113mm FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 17.5mm STD FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 3 STD 101mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 11 STD 117mm FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 10mm LAT FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 7 STD 109mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 0 STD 95mm FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 8.8mm STD FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 6 HI 107mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 10 STD 115mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 1 STD 97mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 4 STD 103mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 5 STD 105mm FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 7.5mm STD FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 8 HI 111mm FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 7 HI 109mm FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 13.8mm LAT FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 15mm LAT FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 4 HI 103mm

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)