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

    CROSSLINK AXIAL AND OFFSET PLATES

    K Number: K923242 · Decision May 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    23
    Review Days
    321

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    Basic Information

    Device Name
    CROSSLINK AXIAL AND OFFSET PLATES
    K Number
    K923242
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Sofamor Danek Mfg., Inc.
    Date Received
    July 2, 1992
    Decision Date
    May 19, 1993
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

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    Other Clearances by Sofamor Danek Mfg., Inc.

    K Number Device Name
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    K930191 DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY
    K932029 TSRH SPINAL SCREWS
    K922486 DANEK TISSUE CUTTING AND REMOVAL SYSTEM
    K930807 SENTRY ANTERIOR SPINAL SYSTEM
    K930710 SENTRY POSTERIOR SPINAL SYSTEM
    K922543 Z-PLATE ANTERIOR FIXATION SYSTEM
    K922672 AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
    K925811 TSRH CENTRAL POST HOOKS
    K921256 LUQUE V SPINAL SYSTEM
    Search all 23 clearances from Sofamor Danek Mfg., Inc. →