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The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

• the use of SYMPHONY OCT System is indicated,
• the use of stereotactic surgery may be appropriate, and
• reference to a rigid anatomical structure, such as a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments can be:

• pre-calibrated with the VELYS™ SPINE Navigation using the VELYS™ SPINE Instrument Arrays,
• pre-calibrated and/or manually calibrated with the Brainlab Navigation System using the UNAS Navigation Arrays,
• manually calibrated with other navigation systems, using tracking arrays supplied by the navigation system manufacturer.

The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial screw placement.

The SYMPHONY™ Navigation Ready Instruments are reusable instruments used for the preparation for and insertion of SYMPHONY OCT screws, in either open or percutaneous procedures. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

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