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

    STRYKER INJECTABLE CEMENT

    K Number: K051603 · Decision Dec 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    2
    Review Days
    198

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    Basic Information

    Device Name
    STRYKER INJECTABLE CEMENT
    K Number
    K051603
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Leibinger Micro Implants
    Date Received
    June 15, 2005
    Decision Date
    December 30, 2005
    Product Code
    MQV
    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
    MQV Filler, Bone Void, Calcium Compound

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    Other Clearances by Stryker Leibinger Micro Implants

    K Number Device Name
    K213777 Stryker Resorbable Fixation System