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

    OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE

    K Number: K133082 · Decision May 20, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    4
    Review Days
    232

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    Basic Information

    Device Name
    OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
    K Number
    K133082
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteosymbionics, LLC
    Date Received
    September 30, 2013
    Decision Date
    May 20, 2014
    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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    Other Clearances by Osteosymbionics, LLC

    K Number Device Name
    K121102 OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
    K111069 OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
    K072601 OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT