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

    SPIN DOWN RAPIDFLAP

    K Number: K031034 · Decision May 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    56
    Review Days
    50

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    Basic Information

    Device Name
    SPIN DOWN RAPIDFLAP
    K Number
    K031034
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Walter Lorenz Surgical, Inc.
    Date Received
    April 1, 2003
    Decision Date
    May 21, 2003
    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 Walter Lorenz Surgical, Inc.

    K Number Device Name
    K063386 LORENZ ORTHODONTIC ANCHORAGE SYSTEM
    K063052 LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES
    K063506 LORENZ STERNAL CLOSURE SYSTEM
    K062842 TWIST DRILL
    K061384 LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM
    K042516 OTOMIMIX
    K030425 LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
    K040990 MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
    K040983 LORENZ SELF-DRILLING IMF SCREW
    K033740 LORENZ STERNAL CLOSURE SYSTEM
    Search all 56 clearances from Walter Lorenz Surgical, Inc. →