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The Carriere® Motion Pro® Clear Bite Corrector is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II and Class III cases with symmetrical and asymmetrical malocclusions and Class I cases with mesially positioned maxillary molars or mandibular crowding. The appliance is indicated for use by dental and orthodontic professionals and is applicable to any patient demographic undergoing orthodontic treatment.

The Carriere Motion Pro Clear Bite Corrector is a single-use, direct bond, esthetic orthodontic appliance made of 17-4 stainless steel and polyethersulfone. It attaches the maxillary or mandibular canine or 1st premolar to the molar to provide a treatment solution for patients with malocclusions of primary, permanent, or mixed dentition. The Carriere Motion Pro Clear Bite Corrector is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II and Class III cases with symmetrical and asymmetrical malocclusions and Class I cases with mesially positioned maxillary molars or mandibular crowding. The appliance is indicated for use by dental and orthodontic professionals and is applicable to any patient demographic undergoing orthodontic treatment. An optional drop-in hook, manufactured from 304 stainless steel, is included and is intended to work in conjunction with the Carriere Motion Pro Clear appliance to facilitate attachment of various orthodontic auxiliaries, such as elastomeric chain, nitinol springs, ligature wire, and elastics.

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The ARC-EX System is intended to deliver programmed transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

The ARC-EX System is intended to be operated in medical centers by Rehabilitation Professionals and at home by Patients and Persons Providing Assistance to the Patient as needed.

The ARC-EX System is a medical device that delivers transcutaneous programmed, Carrier Frequency-enabled electrical spinal cord stimulation (ARC-EX Therapy). The System is intended to be used in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals with cervical spinal cord injury (SCI).

The stimulation is intended to be delivered transcutaneously and the active electrodes are intended to be placed in direct contact with intact skin, in appropriate locations along or near the spine to elicit desired outcomes. The ARC-EX System is intended to be used in a medical center setting by patients and their rehabilitation professionals, and at home by Patients and Persons providing assistance to the patient as needed.

The primary components of the ARC-EX System are:

• ARC-EX Stimulator is an internally powered device equipped with a rechargeable battery. It generates and delivers electrical stimulation to the Electrodes based on commands received from the ARC-EX Programmer.

• ARC-EX Stimulator Charger is a wired charger used to recharge the Stimulator battery.

• ARC-EX Splitter Box is used to connect and transmit current from the Stimulator to the Electrodes (via the Extension Cables).

• ARC-EX Extension Cables are used to connect the Splitter Box to the Electrodes. Two different Extension cable lengths are provided: short Extension Cables (50 cm/19.7 inches long) long Extension Cables (100 cm/39.4 inches long)

• ARC-EX Programmer is an off-the-shelf tablet with the ARC-EX PRO app or the myARC-EX app pre-installed and can be used by the Rehabilitation Professional and the Patient exchange data with the Stimulator.

• Programmer Charger (Tablet Charger) is used to recharge the Tablet battery.

• ARC-EX Case is intended for transportation and storage, in between use, of the ARC-EX System.

The ARC-EX System is intended to be used with the FDA-cleared Axelgaard PALS electrodes (K132422).

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The ROSA Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for total knee replacement surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.

The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan optionally determined pre-operatively using compatible X-ray based surgical planning tools. It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories.

The ROSA Knee System is designed for use on skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA Knee System.

The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Persona Ti-Nidium® CR, Persona Ti-Nidium PS, Persona® PPS® CR, Persona® PPS® PS, Persona SoluTion PPS, Persona IQ® The Smart Knee™, Vanguard® CR, and Vanguard PS.

The ROSA® Knee System for use with the ROSA® RECON platform is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively.

The ROSA® Knee System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal which manages the creation and tracking of surgical cases. The cases reside on the portal until they are uploaded to the ROSA® RECON Platform before surgeries.

If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI system (X-PSI Knee System K171269) to create a 3D model of the patient's femur/tibia and allows the preparation of a pre-operative surgical plan as well as visualization of planned cuts. The pre-operative plan is then matched to the landmarks taken intra-operatively on the patient's bony anatomy. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intra-operative landmarks.

The intraoperative workflow and surgical concepts implemented in the ROSA Knee System remain close to the conventional TKA workflow. As such, at the time of the surgery, the system mainly assists the surgeon in (1) Determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry (planning optionally based on a pre-operative plan using pre-operative imaging), and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.

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The VISERA ELITE III Surgical Imaging System is intended to provide real-time visible and near infrared fluorescence imaging.

Upon intravenous administration and use of ICG consistent with its approved label, VISERA ELITE III Surgical Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the VISERA ELITE III Surgical Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration and use of ICG consistent with its approved label, the VISERA ELITE III Surgical Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The VISERA ELITE III Surgical Imaging System is intended to be used with ancillary equipment for endoscopic diagnosis, treatment, and observation and supports the function of high definition (HD) videoscopes and is Camera Head (CH) compatible.

The following subject devices of the OLYMPUS VISERA ELITE III Surgical Imaging System are identical to and unchanged from the VISERA ELITE III Surgical Imaging System (K242067):

• VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 (Model Number: OLYMPUS OTV-S700) – OLYMPUS OTV-S700 is a video system center that processes electronic signals transmitted from a video endoscope or a camera head and outputs the image signal to a monitor.

  • OTV-S700 3D UPGRADE PACK (Model Number: OLYMPUS MAJ-2511) – A function activation portable memory key accessory that unlocks the 3D software function when connected with VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 to enable 3D observation mode.

• VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 (Model Number: OLYMPUS CLL-S700) – A LED light source that provides examination light to a video endoscope and a camera head.

• 4K Camera Head OLYMPUS CH-S700-XZ-EA (Model Number: OLYMPUS CH-S700-XZ-EA) – A 4K Inline camera head is intended to be used with Olympus endoscopes, the video system center, and other ancillary equipment for the visualization of internal organs (Endoscopic diagnosis), treatment and observation.

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The Firebird SI Navigation System instruments are intended to be used during the preparation and placement of Orthofix Firebird SI Fusion System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Firebird SI Navigation instruments are specifically designed for use with the Medtronic StealthStation System, 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 or pelvis can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Firebird SI Navigation System consists of manual, surgical instruments for use with the Medtronic StealthStation Navigation System via the NavLock Tracker and SureTrak II Large Passive Fighter to assist surgeons in locating anatomical structures in minimally invasive and open procedures for preparation and placement of Firebird SI Fusion System implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. The Firebird SI Navigation System instruments are manufactured from Stainless Steel per ASTM F899 or ASTM A564.

The Firebird SI Navigation System instruments include the following:

• Screw Driver
• Drills
• MDT Inline Adapter

The Firebird SI Navigation System instruments are to be used with the following FDA cleared SeaSpine Spinal System:

• Firebird SI Fusion System

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The Navilas® Laser System is an ophthalmic laser integrated with a digital camera. The Navilas® Laser System is indicated for the treatment of ocular pathology in the anterior and posterior segment of the eye, with supporting imaging functions (capture, display, storage and annotation) of the retina of the eye via color and infrared imaging.

The Navilas® Laser System is intended for use in the posterior segment to perform Retinal Photocoagulation, Panretinal photocoagulation, focal photocoagulation or grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

• Proliferative and non-proliferative diabetic retinopathy
• Macular edema
• Choroidal neovascularization associated with wet age-related macular degeneration
• Age-related macular degeneration
• Central and branch retinal vein occlusion
• Lattice degeneration
• Retinal tears and detachments

Intended for use in the treatment of ocular pathology in the anterior segment including:

• Iridotomy
• Iridoplasty
• Trabeculoplasty

The Navilas Laser System 577SL is a laser photocoagulator with an integrated digital fundus camera. The Navilas Laser System 577SL combines imaging technologies (color and infra-red imaging) with established laser photocoagulation treatment methods by providing the physician a system for imaging and treatment planning prior to the photocoagulation procedure.

The Navilas Laser System 577SL is comprised of:

• A semiconductor laser source that operates at 577nm wavelength. The laser can operate with Continuous Wave (CW) or Micro-Second Pulsing (MSP).
• An integrated delivery system that directs the laser beam through an ophthalmoscope using motorized mirrors.
• A digital camera that provides continuous real-time imaging in color with white light illumination of the fundus, or in monochrome using infrared illumination.
• A software platform that is based on an embedded Windows operating system, that controls the startup, use, calibration, monitoring, and shutdown of the system.

The Navilas Laser System 577SL supports the user during multiple steps of a laser treatment procedure with digital imaging, image storage, planning and laser treatment options including:

Digital imaging - Provided by a color image with white light, supporting mydriatic and nonmydriatic image acquisition (with and without dilated pupils), or a monochrome IR image. Images are presented using a digital display. An illumination mode is selected where images are acquired and either stored, exported or discarded after viewing on the touch sensitive digital display.

Image Storage - Captured images can be digitally stored in the Navilas Laser System 577SL database along with other patient related data to create a complete patient record for future reference. Images from other devices may also be imported and stored.

Planning - Areas identified on acquired or imported images by the user that are selected for future treatment consideration can be marked through the use of treatment planning tools available. The physician has the ability to highlight areas on acquired images (called Points of Interest). These locations are created and manipulated using the touch sensitive digital display.

Laser Treatment - Treatment options are also unchanged from the predicate device with Pre-planned and Ad-hoc Modes available on all Navilas laser models. Pre-positioning of the aiming beam onto locations which are selected by the physician during planning is also facilitated. The position of the aiming beam can be monitored on the real-time image that is displayed on the touch sensitive digital display.

Report generation - Information collected in the database includes images obtained before, during and after treatment. This information can be used for the generation of patient reports for documentation purposes.

The Navilas Laser System 577SL can emit a 577 nm wavelength beam for photocoagulation with power up to 1700 mW and pulse duration up to 4000 ms.

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