A thin metal rod intended to guide the implantation of a pedicle screw during a minimally-invasive procedure, where it can also function as a guide for a gauge to provide a screw length measurement. It is inserted into the pedicle of a vertebra so that a ca...
A hand-held component of an ultrasonic surgical system intended to guide/direct the tip of the system’s holder/tip (not included) which oscillates (vibrates) on hard tissue (e.g., bone) during open or minimally-invasive surgery. It typically has a tubular f...
A collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protect...
A hollow dilator with a tapered distal end intended to enable the gentle insertion of a larger laparoscopic access cannula, necessary when significantly increasing the working access port's lumen, e.g., from 10 to 20 mm diameter. It is commonly used in mini...
A collection of non-sterile surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-ti...
A sterile, invasive, probe-like device intended to be used in conjunction with an MRI-guided laser interstitial thermal therapy (LITT) system to direct and deliver laser energy for ablation of soft-tissue brain lesions. It is stereotactically placed by a ne...
A collection of sterile devices used to perform percutaneous, minimally-invasive lumbar decompression (MILD) for the treatment of various spine conditions, typically in conjunction with an endoscope. It typically includes trocars, cannulae (portals), a retr...
A collection of sterile components of a mechanical skin contouring system intended to temporarily minimize the manifestation of cellulite by transection of the cellulite-tethering fibrous tissue by motorized mechanical means. It consists of template plates,...
A custom-made device intended to be used by a dental surgeon to guide drilling in the jawbone of a patient during the first stage of a guided dental implantation procedure for dental implant or orthodontic mini-implant placement/fixation. It is in the form ...
A non-bioabsorbable, implantable tubular device intended to treat critical lower-limb ischemia by creating a communication (shunt) between an artery and a vein to produce venous arterialization in the below-knee vasculature for restoration of blood flow. It...
A non-sterile, mains electricity (AC-powered) motor component of a mechanical skin contouring system intended to temporarily minimize the manifestation of cellulite by transection of the cellulite-tethering fibrous tissue by motorized mechanical means. It i...
An in vitro diagnostic software program intended to be used for the interpretation of results of an in vitro diagnostic assay [e.g., minimum inhibitory concentration (MIC), mass spectrometry (MALDI-TOF)] performed on a microbial culture isolated from a clin...
An in vitro diagnostic interpretive software program intended to be used in the assessment of risk of progression of chronic kidney disease (CKD). It uses specific algorithms to combine and correlate patient demographics, clinical observations, and the in v...
A short, hollow, rigid tube intended to be percutaneously inserted into the pyloric canal to facilitate the passage of other devices (e.g., guidewire, catheter) through its lumen and into the duodenum/jejunum, typically during a minimally-invasive procedure...