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The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include: Posterior-approach spinal implant procedures, such as pedicle screw placement, with the lumbar region.

The subject devices, Image calibrator-21F and Image calibrator-31F are designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513). The subject devices are modified from previously cleared devices to be compatible with the 21 cm/ 31 cm flat panel C-arm for CT image position and calibration. The software upgrade is due to these newly added Image calibrators and one added function of auto-labeling for CT/C-arm image registration.

The Remex Spine Surgery Navigation instrument is designed for use with Anatase Spine Surgery Navigation System(K230783) and Remex Spine Surgery Navigation System II(K233513). The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include: Posterior-approach spinal implant procedures, such as pedicle screw placement, with the lumbar region.

The Remex Spine Surgery Navigation Instrument is designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513). The Remex Spine Surgery Navigation Instrument consists of the Nav Awl, Nav Drill Guide, Nav Tap, Nav Screwdriver and Nav Handle. 1. Nav Awl: The subject device is intended to support the surgeon to create an entry point before implanting the screw. 2. Nav Drill Guide: The subject device is intended to assist in drilling holes to a desired depth and ensuring proper orientation. 3. Nav Tap: The subject device is intended to create screw threads. 4. Nav Screwdriver: The subject device is intended to driver the screw into the vertebra. Nav Handle: The subject device is intended to connected with Nav Awl, Nav Tap or Nav Screwdriver for navigation tracking purpose.

The Anatase Navi Disposable Instrument is designed for use with Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. are indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative quidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagerv. Example procedures include : Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

The Anatase Navi Disposable Instrument is designed for use with Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. The Guiding awl is intended to support the surgeon to create an entry point before implanting the screw. The Spine pin with DRF-D and MIS LOC with DRF are both intended to fix the DRF on the vertebra by boned pins or the clamp. Once the DRF is fixed on the vertebra, the system can track the position of the patient's vertebra and instruments.

The Remex Spine Surgery Navigation System II, is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative quidance system to enable open or percutaneous image quided surgery by means of registering intraoperative 2D fluoroscopic projections to preoperative 3D CT imagery. Example procedures include: Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

The Remex Spine Surgery Navigation System II, also known as an Image Guided System, is comprised of a platform, clinical software, surgical instruments, and a referencing system. The system uses wireless optical tracking technology to track the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The system helps guide surgeons during spine procedures such as spinal fusion. The software functionality in terms of its feature sets are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views.

The Anatase Spine Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include but are not limited to: Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

The Anatase Spine Surgery Navigation System, also known as an Image Guided System, is comprised of a platform, clinical software, surgical instruments, and a referencing system. The system uses wireless optical tracking technology to track the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The system helps guide surgeons during spine procedures such as spinal fusion. The software functionality in terms of its feature sets are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views.