Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K032815
    Device Name
    PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM
    Manufacturer
    PRECISION SURGERY LIMITED
    Date Cleared
    2004-02-12

    (156 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION SURGERY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Surgery Limited Variable and Fixed Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
    Device Description
    The Precision Surgery Limited Variable and Fixed Cervical Plate System includes plates and screw components. There are three types of plates available, two variable and one fixed. Primary and rescue screws are available.
    Ask a Question

    Page 1 of 1