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510(k) Data Aggregation

    K Number
    K183091
    Device Name
    Elaris Pedicle Screw System
    Manufacturer
    Date Cleared
    2019-08-02

    (269 days)

    Product Code
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    SpineWelding AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Elaris Pedicle Screw System is intended to provide immobilization of spinal segments through posterior, non-cervical, pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following indications: degenerative disc disease (defined as back pain of discogenic origin with deqeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The Elaris Pin polymer can be ultrasonically deposited through the Elaris Pedicle Screw in skeletally mature patients as an adjunct to fusion for the indications listed above.
    Device Description
    The ELARIS Pedicle Screw System consists of the following components: Elaris Pedicle Screws, Elaris Pins, Elaris Rod, Elaris Set Screw, Dedicated Manual Instruments, and an Ultrasonic System, which includes the ultrasonic generator (BoneWelder 150-W1) with corresponding footswitch and power cord, and the spring loaded Elaris Handpiece with the Elaris Connector, which rigidly couples the housing of the Elaris Handpiece with the Elaris Pedicle Screw. The cannulated pedicle screws are available in two diameters and four lengths and contain a distal fenestration to optionally allow injection of resorbable polymer into the cancellous bone of the vertebral body. The Ti alloy screws are multiaxial, and are rigidly attached to the set screw. The Elaris Pin can intraoperatively be inserted into the screws cannulation. The Elaris handpiece can be connected to the pedicle screw head, and using the BoneWelder, the polymer is ultrasonically heated so that it melts and is extruded out of the fenestrations.
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