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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    ABCcolla Bone Graft

    K Number: K171629 · Decision Feb 1, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    4
    Review Days
    244

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    Basic Information

    Device Name
    ABCcolla Bone Graft
    K Number
    K171629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acro Biomedical Co., Ltd.
    Date Received
    June 2, 2017
    Decision Date
    February 1, 2018
    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 Acro Biomedical Co., Ltd.

    K Number Device Name
    K233378 ABCcolla® Collagen ADM Scaffold
    K212156 ABCcolla Bone Matrix
    K162348 ABCcolla Collagen Matrix