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

    TSRH CENTRAL POST HOOKS

    K Number: K914966 · Decision May 12, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    23
    Review Days
    189

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    Basic Information

    Device Name
    TSRH CENTRAL POST HOOKS
    K Number
    K914966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sofamor Danek Mfg., Inc.
    Date Received
    November 5, 1991
    Decision Date
    May 12, 1992
    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 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
    K923242 CROSSLINK AXIAL AND OFFSET PLATES
    K922543 Z-PLATE ANTERIOR FIXATION SYSTEM
    K922672 AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
    K925811 TSRH CENTRAL POST HOOKS
    Search all 23 clearances from Sofamor Danek Mfg., Inc. →