BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ortho1399 (SN,EP1) - 10x17 and 12x17 Extended Stems

    Reg #: 1720929 · FEI: 1720929 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    1720929
    FEI Number
    1720929
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9120 SOUTH 150 EAST
    City
    Sandy
    State
    UT
    ZIP
    84070
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053293

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL

    Proprietary Names

    Ortho1399 (SN,EP1) - 10x17 and 12x17 Extended Stems Ortho1399 (SN,EP1) - Encompass Press-fit Hip Stem

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)