BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 5 HI 145mm

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    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

    510(k) Number
    K001991

    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/Polymer, Porous Uncemented LPH

    Proprietary Names

    FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 5 HI 145mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 5 STD 145mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 8 HI 160mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 4 HI 140mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 3 STD 135mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 10 HI 170mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 6 HI 150mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 7 STD 155mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 8 STD 160mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 4 STD 140mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 1 HI 125mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 9 HI 165mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 7 HI 155mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 9 STD 165mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 3 HI 135mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 6 STD 150mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 10 STD 170mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 2 STD 130mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 2 HI 130mm FEMORAL STEM 12/14 TAPER TAPERED w/POROCOAT® SIZE 1 STD 125mm SUMMIT POROUS

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)