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

    SILHOUETTE SPINAL FIXATION SYSTEM

    K Number: K993067 · Decision Nov 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    7
    Review Days
    64

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    Basic Information

    Device Name
    SILHOUETTE SPINAL FIXATION SYSTEM
    K Number
    K993067
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sulzer Spine-Tech
    Date Received
    September 13, 1999
    Decision Date
    November 16, 1999
    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 Sulzer Spine-Tech

    K Number Device Name
    K022374 CADENCE SPINAL FIXATION SYSTEM
    K020344 RPX TITANIUM CEMNT RESTRICTOR
    K020196 MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
    K012173 DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
    K012305 MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
    K992276 MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM