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

    OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT

    K Number: K111069 · Decision Sep 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    157

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    Basic Information

    Device Name
    OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
    K Number
    K111069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteosymbionics, LLC
    Date Received
    April 18, 2011
    Decision Date
    September 22, 2011
    Product Code
    MNF
    Advisory Committee
    General, Plastic Surgery
    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
    MNF Implant, Temporal

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    Other Clearances by Osteosymbionics, LLC

    K Number Device Name
    K133082 OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
    K121102 OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
    K072601 OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT