Spine Smith L.P.
E-Mail:
Address: 93 Red River, Austin, Texas 78701, USA
Phone: +1-(512)-206-0770 | Map/Directions >>
Profile: Spine Smith L.P. designs, develops and markets implants & biologics for surgical fixation, correction & tissue regeneration of the spine. Our product area includes medical devices, regenerative biologics, pre-surgical orthopedic conditioning and cost reduction & inventory management. Our Cimplicity ™ system is an anterior cervical interbody fusion device. The Cimplicity system is ideal to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The device is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The system is intended to be used with autograft or allograft bone. Our regenerative biologics include fusionary A and fusionary B. Our Fusionary ™ process promotes the regeneration of tissue in spinal procedures by delivering a highly concentrated amount of autologous adult stem cells.
FDA Registration Number: 3006404071
20 Products/Services (Click for related suppliers)
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| • 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) |
| • Broach (FDA Code: HTQ / 888.4540) |
| • Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP / 888.3080) |
| • Drill Bit (FDA Code: HTW / 888.4540) |
| • Drill Brace (FDA Code: HXY / 888.4540) |
| • Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX / 888.3080) |
| • Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY / 878.4680) A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds. |
| • Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540) |
| • Pin Crimper (FDA Code: HXQ / 888.4540) |
| • Prosthesis Driver (FDA Code: HWR / 888.4540) |
| • Screwdriver (FDA Code: HXX / 888.4540) |
| • Socket Pusher (FDA Code: HXO / 888.4540) |
| • 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 Vertebral Body Replacement Device (FDA Code: MQP / 888.3060) |
| • Surgical Instrument Tray (FDA Code: FSM / 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 Retractor (FDA Code: GAD / 878.4800) |
| • Surgical Retractor Systems (FDA Code: GAD / 878.4800) |
| • Tamps (FDA Code: HXG / 888.4540) |
