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The Midas Rex MR8 Depth Stop attachment and tools are indicated for the incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

The Midas Rex MR8 Depth Stop attachment and tools are intended to create a cranial access hole of a known diameter and depth.

The Midas Rex™ attachments and dissecting tools for Mazor are indicated for the incision/cutting, drilling, burring, and removal of hard tissue and bone in open and minimally invasive spine procedures. Computer-assisted surgery and its associated applications are intended as an aid for locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition for which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as a long bone or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

Midas Rex™ attachments and surgical dissecting tools for Mazor are intended for the incision/cutting, drilling, burring, and removal of hard tissue and bone. The subject instruments are designed to be utilized through a cannula, for use with the Mazor X Stealth Edition™ system in open and minimally invasive spine procedures. The subject devices perform the intended function as part of the existing Medtronic Midas Rex TM surgical drill systems which consist of the subject attachments and dissecting tools, electric and pneumatic drill handpieces and system accessories.

The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use 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 long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

The Stealth-Midas MR8 consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation in conjunction with the StealthStation S8 System and the Integrated Power Console (IPC). The system allows the navigation of a selection of currently available surgical dissecting tools. The navigated handpieces are provided non-sterile and are reusable. The associated attachments are provided non-sterile and are reusable. The associated surgical dissecting tools and MR8 ClearView burs are provided sterile and are single-use.

The Medtronic MR8 Drill System is incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures. Additionally, the MR8 Drill System is indicated for the incision/cutting, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures: - Lumbar Microdiscectomy - Lumbar Stenosis Decompression - Posterior Lumbar Interbody Fusion (PLIF) - Transforaminal Lumbar Interbody Fusion (TLIF) - Anterior Lumbar Interbody Fusion (ALIF) - Direct Lateral Interbody Fusion (DLIF) The Midas Rex MR8 ClearView Tools are used only in conjunction with the MR8 Drill System to perform as intended. Please refer to the Midas Rex MR8 Drill System and associated User's Guides for the Indications of Use.

The Medtronic MR8TM Drill System is comprised of both Electric and Pneumatic powered, rotary cutting handpieces, attachments, surgical dissecting tools, and accessories designed to remove soft and hard tissue, bone, and biomaterials during various surgical procedures. The surgical dissecting tools are provided sterile and are single use, while the rest of the system components are provided non-sterile and are reusable. The Midas Rex™ MR8TM ClearView™ Tools are designed to interface with Midas Rex™ MR8 Drill System motor to support bone and tissue removal during surgical procedures. The Midas Rex™ MR8™ ClearView™ Tools are part of a larger portfolio of tools and accessories designed to be used with the Midas Rex™ MR8 System/Platform.

The Electric Drill System is a electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries. Additionally, the Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures: - Lumbar Microdiscectomy - Lumbar Stenosis Decompression - Posterior Lumbar Interbody Fusion (PLIF) - Transforaminal Lumbar Interbody Fusion (TLIF) - Anterior Lumbar Interbody Fusion (ALIF) - Direct Lateral Interbody Fusion (DLIF)

The Electric Drill System consists of an electric Integrated Power Console, Electric Foot Control unit with Y-Splitter, Connection Cables, Irrigation/Cooling Sets including a remote Irrigation Control Unit, and various Electric Handpieces and/or electric motors and Attachments to drive various Surgical Dissecting Tools. The Integrated Power Console device of the Electric Drill System can also function as an endoscope lens cleaning system.

The Medtronic MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

The MR8 Drill System consists of electric and pneumatic drill handpieces, attachments, surgical dissecting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The surgical dissecting tools are provided sterile and are single use.

The Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries. Additionally, the Pneumatic Drill System is incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures: - Lumbar Microdiscectomy - Lumbar Stenosis Decompression - Posterior Lumbar Interbody Fusion (PLIF) - Transforaminal Lumbar Interbody Fusion (TLIF) - Anterior Lumbar Interbody Fusion (ALIF) - Direct Lateral Interbody Fusion (DLIF)

The Pneumatic Drill System is a pneumatically powered high-speed drill system consisting of a choice of various Pneumatic Handpieces (comprising of a High Pressure and Exhaust Hose, and Handpiece) equipped with a foot or finger controller, Pneumatic Foot Control Unit, Surgical Dissecting Tools, System Accessories, and where applicable, Attachments to support various Surgical Dissecting Tools, and System Accessories.

The Stealth-Midas System is indicated for the drilling, burring and removal of hard tissue and bone in spinal surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use 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 long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

The Stealth-Midas System consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation with the StealthStation System. The system allows the navigation of a selection of currently available surgical dissecting tools. The navigated handpieces are provided non-sterile and are reusable.

The Medtronic Midas Rex MR7 System is a pneumatically operated surgical instrument system. The pneumatic motors provide power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

The Midas Rex MR7 Pneumatic High Speed System includes a pneumatic motor; either the MR7 option which is foot controlled or the MR7t option which is finger controlled. A coaxial hose system, designed with an inner high-pressure supply hose located within an exhaust hose, connects the motor to the foot controller. One end of the coaxial hose system is permanently attached to the motor. The inner high-pressure hose supplies the compressed gas to the internal components of the motor. The outer hose captures the exhausted gas from the internal components of the motor and transports this exhaust gas to the diffuser section of the lubricant diffuser cartridge located on the foot control end of the hose at floor level. This self-contained lubricant/diffuser system consists of two components; a permanently attached receptor base on the foot control connector section of the hose and a disposable lubricant/diffuser cartridge. The cartridge provides two functions; the lubrication for the internal components of the motor and the capture of the exhausted gas from the motor. the foot or finger controller is used to activate the flow of compressed air or nitrogen (gas) into the pneumatic motor and is connected to the pressure regulator of the gas supply system through the regulator hose. The Midas Rex MR7 Pneumatic High Speed System is intended to be used with all existing Midas Rex Legend attachments and dissecting tools previously cleared through K020069.

The Midas Rex Curved Burs are intended for use in surgical procedures for the following medical applications: Neurosurgical; Spine; Ear, Nose and Throat (ENT), Orthopedic Surgery, and General and Plastic Surgery including Maxillofacial, Craniofacial and Sternotomy. The Curved bur will be used to cut and/or remove bone and biomaterial.

Midas Rex Curved Bur is a sterile, single use, one piece device which includes the dissection tool (bur head, bur wire, bur tang) and the protective tube / cooling sleeve / hub. The hub connects and locks into the existing Legend telescoping attachment base. Legend telescoping attachment base connects to the Legend motor. The motor provides the power to rotate the dissecting tool / bur. The attachment / tube provide support and stability to the dissecting tool. The bur head which may be fluted or diamond coated, is the actual cutting tip on the device.