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

    POLYBONE GRANULE & BLOCK

    K Number: K082338 · Decision Oct 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    4
    Review Days
    63

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    Basic Information

    Device Name
    POLYBONE GRANULE & BLOCK
    K Number
    K082338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kyung Won Medical Co., Ltd.
    Date Received
    August 14, 2008
    Decision Date
    October 16, 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 Kyung Won Medical Co., Ltd.

    K Number Device Name
    K100373 TYCHE PEDICLE SCREW SYSTEM
    K092194 POLYBONE DENTAL
    K070012 POLYBONE