Profile: Spinevision, Inc.provides spinal treatment products. We offer PLUS®, X-PLUS™, UNI-Thread®, Spacevision® and C3® products. UNI-Thread® versatile thoraco-lumbar spinal system has a single threaded screw and three dimensional connector design which allows adjustment of the height of both components at any stage of the procedure. The bone screw depth is easily optimized at any time. Spacevision® p-cage system is intended as a partial vertebral body replacement in the thoraco-lumbar spine. P-cages offer wide opening to allow for optimal bone graft filling and fusion.
FDA Registration Number: 1067145
39 Products/Services (Click for related suppliers)
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| • Anterior Cervical Plate Systems |
| • Awl (FDA Code: HWJ / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. |
| • Bender (FDA Code: HXW / 888.4540) |
| • Bone Taps (FDA Code: HWX / 888.4540) |
| • Bone Trephine (FDA Code: HWK / 888.4540) |
| • Cervical Spine Retractor System, Hand Held Instruments |
| • Curettes (FDA Code: HTF / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
| • Depth Gauge (FDA Code: HTJ / 888.4300) A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone. |
| • Drill Bit (FDA Code: HTW / 888.4540) |
| • Evoked Response Electrical Stimulator (FDA Code: GWF / 882.1870) An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response. |
| • Flexible Depth Gauge (FDA Code: HTJ / 888.4300) |
| • Impactor (FDA Code: HWA / 888.4540) |
| • Instrument Surgical Guide (FDA Code: FZX / 878.4800) |
| • Medical Probes (FDA Code: HXB / 888.4540) |
| • Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800) |
| • Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540) |
| • Orthopedic Spatula (FDA Code: HXR / 878.4800) |
| • Probes (FDA Code: HXB / 888.4540) |
| • Probes (FDA Code: HXB / 888.4540) |
| • Prosthesis Driver (FDA Code: HWR / 888.4540) |
| • Reamer (FDA Code: HTO / 888.4540) |
| • Screwdriver (FDA Code: HXX / 888.4540) |
| • Small Depth Gauge (FDA Code: HTJ / 888.4300) |
| • Spinal Implants |
| • Spinal Interlaminal Fixation Appliance (FDA Code: KWP / 888.3050) A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome. |
| • Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ / 888.3060) A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back," scoliosis (lateral curvature of the spine), or other conditions. |
| • Spinal Pedicle Fixation Orthosis (FDA Code: MNI / 888.3070) Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors. |
| • Spinal Vertebral Body Replacement Device (FDA Code: MQP / 888.3060) |
| • SpineAssist System |
| • Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH / 888.3070) |
| • Surgical Hammer (FDA Code: FZY / 878.4800) |
| • Surgical Instrument Tray (FDA Code: FSM / 878.4800) |
| • Surgical Pliers (FDA Code: HTC / 878.4800) |
| • Surgical Retractor (FDA Code: GAD / 878.4800) |
| • Surgical Retractor Systems (FDA Code: GAD / 878.4800) |
| • Templates (FDA Code: HWT / 888.4800) A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting. |
| • Thoraco-Lumbar Spinal Systems |
| • Wire Cutters (FDA Code: HXZ / 888.4540) |
| • Wrench (FDA Code: HXC / 888.4540) |