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

    Patient Contoured Implant-PEEK (PCI-PEEK)

    K Number: K151382 · Decision Nov 9, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    20
    Review Days
    171

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    Basic Information

    Device Name
    Patient Contoured Implant-PEEK (PCI-PEEK)
    K Number
    K151382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KLS Martin L.P.
    Date Received
    May 22, 2015
    Decision Date
    November 9, 2015
    Product Code
    GXN
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXN Plate, Cranioplasty, Preformed, Non-Alterable

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