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

    BRYAN POSTERIOR SPINAL FIXATOR (BPSF)

    K Number: K953416 · Decision Oct 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    5
    Review Days
    85

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    Basic Information

    Device Name
    BRYAN POSTERIOR SPINAL FIXATOR (BPSF)
    K Number
    K953416
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Arcan Orthopaedic Corp.
    Date Received
    July 10, 1995
    Decision Date
    October 3, 1995
    Product Code
    MNH
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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    Other Clearances by Arcan Orthopaedic Corp.

    K Number Device Name
    K971457 BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED
    K955927 BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)
    K945435 BRYAN POSTERIOR SPINAL FIXATOR (BPSF)
    K914548 BRYAN SPINAL FIXATER (BSF)