BEUDAMED
    FDA Registration Active 🇮🇸 Iceland

    Total Knee Junior

    Reg #: 3003764610 · FEI: 3003764610 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    40
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    OSSUR H/F
    Registration Number
    3003764610
    FEI Number
    3003764610
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    GRJOTHALS 1-5
    City
    REYKJAVIK
    Country
    IS

    Owner / Operator

    Firm Name
    OSSUR Americas
    Operator Number
    9026971
    Address
    200 Spectrum Center Drive, Suite 700
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    US Agent

    Business Name
    Ossur
    Contact Name
    Katla Axelsdottir
    Address
    200 Spectrum Center Drive, Suite 700
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 3823833

    Products

    Device Name Product Code
    Joint, Knee, External Limb Component ISY

    Proprietary Names

    Total Knee Junior Mauch Knee Total Knee 1900 Total Knee 2100 Rheo Knee Locking Knee Cheetah Knee Balance Knee OFM1 OH7 Knee Haiti Knee Balance Knee OFM1 SE OHP3 Knee OH5 Knee OP2 Knee OP4 Knee Balance Knee OFM2 Balance Knee OM8 SE Paso Knee OP5 Knee OP2 Knee SE Balance Knee OM8 Junior Shin Ferrule Aspire M1 Knee caps Knee cap, jr Shin Fairing, Black Aspire H1 Aspire M3 Aspire P1 Aspire M2 Season Guard Shin Ferrule For Balance Knee Rheo Knee XC Mauch Knee Plus Ossur Logic Total Knee 2000 Power Knee Battery Power Knee Navii Balance Knee OFM2 SE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device