BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

    K Number: K190991 · Decision Aug 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    2
    Review Days
    122

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    Basic Information

    Device Name
    Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
    K Number
    K190991
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)
    Date Received
    April 15, 2019
    Decision Date
    August 15, 2019
    Product Code
    MBH
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

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