BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Robling1585 (SP) - Fibulink Syndemosis Repair Kit/SS

    Reg #: 1047843 · FEI: 1047843 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    1047843
    FEI Number
    1047843
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2072 SOUTHPORT RD., HWY. 295
    City
    SPARTANBURG
    State
    SC
    ZIP
    29306
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162805

    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
    Washer, Bolt Nut HTN

    Proprietary Names

    Robling1585 (SP) - Fibulink Syndemosis Repair Kit/SS

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)