BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    PoreStar Patient Specific Implant

    K Number: K171037 · Decision Dec 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    265

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    Basic Information

    Device Name
    PoreStar Patient Specific Implant
    K Number
    K171037
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anatomics Pty, Ltd.
    Date Received
    April 6, 2017
    Decision Date
    December 27, 2017
    Product Code
    JOF
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOF Polymer, Ent Synthetic, Porous Polyethylene

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    Other Clearances by Anatomics Pty, Ltd.

    K Number Device Name
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