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Synvasive Technology, Inc.

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Contact: Gordon Smith
Web: http://www.synvasive.com
E-Mail:
Address: 4925 Robert J. Mathews Parkway, El Dorado Hills, California 95762, USA
Phone: +1-(916)-939-3913, 800-925-2337 | Fax: +1-(916)-939-3919, 866-714-6007 | Map/Directions >>
 
 

Profile: Synvasive Technology, Inc. specializes in providing operative solutions to enhance reconstructive surgery. We develop, manufacture and distribute patented & proprietary instruments enhancing reconstructive orthopedic surgery. The eLIBRA dynamic knee balancing system™ provides patient specific soft-tissue balancing, using wireless force-sensing technology, with digital confirmation. eLIBRA® acts as an articular spacer, establishing the optimal position of the femoral implant, in dynamic harmony with the patient's ligament characteristics. As a result, a less-invasive surgical course can be taken, while achieving excellent stability, range of motion, and patella tracking. The Stablecut® cutting end is perpendicular to the length of the blade with a supporting tooth profile. This creates a cutting action that centers the contact between the blade and the bone within the arc of oscillation. Regardless of the path guided by the surgeon, Stablecut® technology reduces the erratic motion of the oscillating saw, assuring surgical control in a restricted joint space, optimal for MIS procedures. The cutting action of Stablecut® also reduces the pressure imparted by the surgeon during a resection, minimizing friction and excessive heat.

FDA Registration Number: 2950261

7 Products/Services (Click for related suppliers)  
• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820)
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
• Instrument Surgical Guide (FDA Code: FZX / 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.
• Intraoperative Orthopedic Joint Assessment Aid (FDA Code: ONN / 882.4560)
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
• Ligament Drill Guide (FDA Code: LXI / 878.4820)
• Orthopaedic Instruments
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 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.
• Orthopedic Surgical Table and Accessories (FDA Code: JEB / 878.4950)
A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

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