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

    MEDPOR CUSTOMIZED SURGICAL IMPLANT

    K Number: K083621 · Decision Feb 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    19
    Review Days
    57

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    Basic Information

    Device Name
    MEDPOR CUSTOMIZED SURGICAL IMPLANT
    K Number
    K083621
    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
    Porex Surgical, Inc.
    Date Received
    December 8, 2008
    Decision Date
    February 3, 2009
    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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    K040364 MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
    K021357 MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
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