Search Results

The Vycor Viewsite Brain Access System (VBAS) is intended to provide for access and allow for visualization of the surgical field during brain and spine surgery.

The Vycor Medical Surgical Access System (VBAS) includes a family of retractor devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spinal region. The subject device is comprised of the modified version of the predicate device cleared under #K060973 together with the optional Alignment clip (A)C component. The models designated with post characters "AC" includes the Alignment Clip ("AC") included separately in the packaging. This is available for all models other than the 6mm size. The AC may be optionally attached to aid in centering third party navigational and image guided system ("IGS") pointers or probes ("pointer"). Like the predicate, the subject device consists of an introducer and port. The port and introducer are packaged assembled and ready for use. Upon insertion of the device, the introducer is removed and the port is left in place. The introducer has a length greater than the port. The smooth and soft tapered introducer works to spread apart the brain or other portions of delicate tissue. Upon removal of the introducer, the port provides a hollow working channel allowing the surgeon access to the target tissues. The AC optional component was designed to make the VBAS easier to use with IGS by enabling the IGS pointer to be centered and held in place: - . Designed to accommodate a range of commonly-used pointers - . Securely clips onto the VBAS device when used - Provides insertion direction to center the pointer in the device and ensure vertical alignment - Provides locking mechanism to securely hold the pointer in place and therefore enable the pointer and VBAS to be one integrated unit freeing up one of the surgeon's hands

The Expandable Port is intended to provide access, allow visualization of the surgical field, and retraction of soft tissue during neurological cranial surgery. The device is indicated for use in surgery during which subcortical access is required.

The MindsEye Expandable Port is a single use, minimally invasive intracranial medical device designed to provide access and allow visualization to the surgical field while retracting subcortical soft tissues during neurological cranial surgery. Its design allows the user to place the port while collapsed in its minimal form for atraumatic access to the subcortical space. After placement, the port can be expanded radially to create a working channel to the target surgical location. The user is able to expand the port to the desired working channel diameter appropriate for the surgical plan then collapse the port upon surgical completion for safe removal. The working channel diameter may be adjusted as needed by the user throughout surgery. The MindsEye device is expected to be used in conjunction with other standard, commercially available intracranial medical devices, such as an aspirator, micro/endo/exoscope, irrigation, electrosurgical systems/tools and/or hemostatic agents. In addition, MindsEye is compatible with existing optical navigation systems for accurate target acquisition and may be attached to other commercial retraction systems according to user preference. The MindsEye device is made of biocompatible, medical grade materials (metals and polymers) with no software or electrical components. The MindsEye device and its components are provided sterile and not reusable. MindsEye is comprised of the following components and is available in three lengths (Table 1). - Port with attached Sheath - Obturator and Guide - Optional Support System consisting of support clips, post, and legs

The device intended for use as a specialized manual surgical instrument. It is reusable and intended to provide access to the thoracic and lumbar spinal column during minimally invasive and endoscopic surgical provides a selflocking type surgical retraction system with inflatable tissue protectors.

GEISTER Medizintechnik GmbH Self-retaining Retractors are reusable manual instruments made from stainless steel, PEEK or titanium. They are sold unsterile and can be re-processed according the instructions for use.

To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following: - Primary/Secondary Brain Tumors - · Vascular Abnormalities/Malformations · Intraventricular Tumors/Cysts

The NICO BrainPath and accessories are designed to provide minimally invasive access to neurological tissues. The design specifically supports the creation of an atraumatic surgical corridor to access the brain. These BrainPath devices are part of what is being called the BrainPath Approach™, which integrates the expanding neurosurgical armamentarium of trajectory planning and navigation, optics, corridor resection and biopsy, and tissue preservation. To date, the BrainPath technology has been used to successfully access primary and secondary brain tumors, vascular abnormalities or malformations, and intraventricular tumors and cysts. The BrainPath consists of multiple-sized reusable and re-sterilizable obturators with coordinating single patient use disposable sheaths. The obturator and sheath are assembled in the operating room immediately prior to use. After placement, the obturator is removed leaving behind the sheath which provides a 13.5 mm or 11 mm surgical corridor.

The MEDICON Spinal Spreading Systems are used to spread soft tissue and maintain surgical access in spine surgery and may only be used by surgeons with proper training and adequate experience in spine surgery.

The MEDICON Spinal Spreading System is made up of multiple reusable manual spreader systems. The spreaders include components for all approaches in spine surgery, including those specifically for cervical spine surgery, as well as inter-laminar, trans-laminar, extra-foraminal and dorsolateral approaches. The multiple components support classic and minimally invasive procedures. The components are made from a radiolucent x-ray compatible material, from titanium, some from stainless steel, and some from anodized aluminum.

The Phantom™ Fukushima and Mastability Neurological Holding Systems are intended to provide access and allow visualization of the surgical field, and to retract soft tissue during neurological cranial procedures.

Not Found

Fetzer Medical Self-Retaining Retractors are intended to hold the edges of a wound open during spinal surgery.

Fetzer Medical Self-retaining Retractors are reusable manual instruments made from stainless steel, aluminum or titanium. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use. Devices are available with the following features: frame type retractors, Ring handle retractors, MIS Port retractor.

To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following: - Primary/Secondary Brain Tumors - Vascular Abnormalities/Malformations - Intraventricular Tumors/Cysts

The NICO BrainPath and Accessories are designed to provide minimally invasive access to neurological tissues. The design specifically supports the creation of an atraumatic surgical corridor to access most areas of the brain. The BrainPath also facilitates the expanding neurosurgical armamentarium of trajectory planning software (e.g., Synaptive® Medical Inc. BrightMatter® Planning Software, K140337), navigation (e.g., Synaptive BrightMatter Navigation System, K142024), optics, corridor resection (e.g., NICO Myriad), and biopsy. To date, the BrainPath technology has been used to successfully access primary and secondary brain tumors, vascular abnormalities or malformations, and intraventricular tumors and cysts. The BrainPath consists of multiple-sized reusable and re-sterilizable obturators with coordinating single patient use disposable sheaths. The obturator and sheath are assembled in the operating room immediately prior to use. After placement, the obturator is removed leaving behind the sheath which provides a 13.5 mm surgical corridor to the lesion or abnormality. The BrainPath Accessories include a "manipulation tool," which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. The accessories also include "shepherd's hooks" for attaching to various commercially available retractors, and a sterilization tray for the reusable components (i.e., obturators and manipulation tools).

To provide for access and allow for visualization of the surgical field during brain and spinal surgery.

The NICO Brain Port is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths. The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. The Brain Port system also includes a "manipulation tool", which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. Finally, the Brain Port includes a custom sterilization tray which houses all reusable components (obturators and manipulation tools).