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The Ultrazonix Spine Minimal-Invasive Disc System is intended for use by professional medical personnel for coagulation and decompression of intervertebral disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. The safety and efficacy of this device has not been established in the thoracic and cervical intervertebral regions of the spine and should not be used in those regions.

The Ultrazonix Spine Minimal-Invasive Disc System is intended for use by professional medical personnel for coagulation and decompression of intervertebral disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. The safety and efficacy of this device has not been established in the thoraci and cervical intervertebral regions of the spine and should not be used in those negions. The Ultrazonix Spine Minimal-Invasive Disc System is comprised of a non-disposable Control Unit, and a sterile, single-use Probe Kit. These two major component parts are described as follows: a) Non disposable Control Unit This contains a power supply, a high frequency-generator, an amplifier, an independent safety system and a user interface with an alphanumerical display and a key pad and a foot-operated switch. The probe and a foot-operated switch are connected to the Control Unit. High frequency induced ultrasound is emitted from the probe and controlled by means of the foot-operated switch. b) Sterile, single-use Probe Kit, consisting of A blunt 500 mm long stainless steel Guide Pin with a diameter of 2 mm. The Guide Pin is used as a pathfinder to navigate towards the spinal disk under fluoroscopic guidance. A 5.3 mm Dilator which is used to prepare a canal for the Introducer. It has a conical front which ensures as little harm as possible is done to adjacent tissue and blood vessels A 6 mm Introducer which is a thin walled, approximately 180 mm long tube with a handle to be used as a guide for the Probe. It is placed over the Dilator and when the desired position against the disk is reached the Guide Pin and the Dilator are removed and The ultrasonic Probe is inserted into the Introducer. It consists of a thin shaft with a piezo ceramic transducer placed at the front /tip.