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

    ROP Resorbable Hemostasis Material

    K Number: K153095 · Decision Feb 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    1
    Review Days
    114

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    Basic Information

    Device Name
    ROP Resorbable Hemostasis Material
    K Number
    K153095
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Resorbable Orthopedic Products, LLC
    Date Received
    October 26, 2015
    Decision Date
    February 17, 2016
    Product Code
    MTJ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MTJ Wax, Bone

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