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

    SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS

    K Number: K936294 · Decision Dec 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    23
    Review Days
    739

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    Basic Information

    Device Name
    SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
    K Number
    K936294
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Sofamor Danek Mfg., Inc.
    Date Received
    December 10, 1993
    Decision Date
    December 19, 1995
    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
    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
    K921256 LUQUE V SPINAL SYSTEM
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