CoreLink Navigation Instruments

CoreLink Navigation Instruments is indicated for use during the preparation and placement of CoreLink implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation S8 System (V1.2.0), which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments is indicated for use during the preparation and placement of CoreLink implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation S8 System (V1.2.0), which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures. The purpose of this submission is to offer compatibility of the previously cleared CoreLink Navigation Instruments for sacroiliac fusion implants with additional CoreLink Sacroiliac Screws and to update the sacroiliac navigation instrument set.