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510(k) Data Aggregation

    K Number
    K103819
    Device Name
    PSL ANTERIOR CERVICAL PLATE SYSTEM
    Manufacturer
    PRECISION SURGERY LTD.
    Date Cleared
    2011-02-15

    (47 days)

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

    PRECISION SURGERY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PSL Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: 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 PSL Anterior Cervical Plate (ACP) System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.
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    K Number
    K103838
    Device Name
    FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
    Manufacturer
    PRECISION SURGERY LTD.
    Date Cleared
    2011-02-15

    (47 days)

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

    PRECISION SURGERY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intuitive Anterior Cervical System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: 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. WARNING: The Intuitive Anterior Cervical System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
    Device Description
    The Intuitive Anterior Cervical System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.
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    K Number
    K073708
    Device Name
    FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
    Manufacturer
    PRECISION SURGERY LTD.
    Date Cleared
    2008-06-03

    (155 days)

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

    PRECISION SURGERY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Surgery Limited Fixed, Variable and Corpectomy 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. WARNING: The Precision Surgery Limited Fixed, Variable and Corpectomy Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
    Device Description
    The Precision Surgery Limited Fixed, Variable & Corpectomy Cervical Plate System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.
    Ask a Question

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