Profile: Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments and promotes active fusion in the lumbar & sacral spine. Its uniquely designed dynamic hinged screw provides optimal user-friendliness and easy assembly of the construct. Our system has HA coating, sterile packaging and is made of titanium construction. Our Obelisc™ implant system provides stability when placed between the vertebral bodies, facilitates spinal distraction and provides stable support under pressure. Our implant is easy to use and can save surgical time. It has exact height adjustments, low profile distractor and modular end caps.
FDA Registration Number: 9612420
US Agent: Hans Stover / Ulrich Medical Usa, Inc.
Phone: +1-(636)-519-0268 Fax: +1-(636)-519-0271 E-Mail: spine
ulrichmedicalusa.com
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• Screwdriver (FDA Code: HXX / 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. |
• Small 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. |
• Speculum Accessories (FDA Code: FXG / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories. |
• Spinal Implants |
• 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 Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB / 888.3070) |
• Spinal Vertebral Body Replacement Device (FDA Code: MQP / 888.3060) |
• Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH / 888.3070) |
• Surgical Curette (FDA Code: FZS / 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. |
• Surgical Instrument Tray (FDA Code: FSM / 878.4800) |
• Surgical Knife (FDA Code: EMF / 878.4800) |
• Surgical Orthopedic Scissors (FDA Code: HRR / 888.4540) |
• Surgical Retractor (FDA Code: GAD / 878.4800) |
• Surgical Retractor Systems (FDA Code: GAD / 878.4800) |
• Surgical Stripper (FDA Code: HRT / 888.4540) |
• Surgical Trays (FDA Code: LRP / 878.4800) |
• Surgical Trays (FDA Code: LRP / 878.4800) |
• Wire Twisters (FDA Code: HXS / 888.4540) |
• Wrench (FDA Code: HXC / 888.4540) |