BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    COMPORUS

    K Number: K062691 · Decision Apr 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    6
    Review Days
    582

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    Basic Information

    Device Name
    COMPORUS
    K Number
    K062691
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Takiron Co., Ltd.
    Date Received
    September 11, 2006
    Decision Date
    April 15, 2008
    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 Takiron Co., Ltd.

    K Number Device Name
    K081390 BIOACTIF OSTEOTRANS INTERFENCE SCREW
    K073006 OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
    K073312 OSTEOTRANS-OT SCREW
    K073311 OSTEOTRANS-OT PIN
    K061881 OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM