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

    BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED

    K Number: K971457 · Decision Jul 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    5
    Review Days
    110

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    Basic Information

    Device Name
    BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED
    K Number
    K971457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arcan Orthopaedic Corp.
    Date Received
    March 28, 1997
    Decision Date
    July 16, 1997
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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    Other Clearances by Arcan Orthopaedic Corp.

    K Number Device Name
    K955927 BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)
    K953416 BRYAN POSTERIOR SPINAL FIXATOR (BPSF)
    K945435 BRYAN POSTERIOR SPINAL FIXATOR (BPSF)
    K914548 BRYAN SPINAL FIXATER (BSF)