Dfine, Inc.

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Contact: Sandeep Saboo
Web: http://www.dfineinc.com
E-Mail:
Address: 3047 Orchard Parkway, San Jose, California 95134, USA
Phone: +1-(408)-321-9999 | Fax: +1-(408)-321-9401 | Map/Directions >>

Profile: Dfine, Inc. develops devices that treat vertebral compression fractures and other spinal disorders in a minimally invasive manner to improve patient's life. We provide RF kyphoplasty procedure with the Stabilit™ vertebral augmentation system. It combines the benefits of site-specific cavity creation, controlled cement delivery, and potential for height restoration with ultra-high viscosity bone cement. During the procedure, radio frequency energy is applied to specially formulate energy-responsive bone cement to create ultra-high viscosity cement. It is then delivered into a cavity within the vertebra using a remote hand switch that allows physician to remain up to 10 feet from the fluoroscopic field, potentially reduce physicians exposure to radiations.

7 Products/Services (Click for related suppliers)

• Cement Dispenser (FDA Code: KIH / 888.4200)

A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.

• Cement Mixing Equipment (FDA Code: JDZ / 888.4210)

A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (888.3027).

• Medical Devices for Ambulatory Treatment of Spinal Disorders

• 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.

• Osteotomes

• Vertebral Augmentation Systems

• Vertebroplasty Bone Cement (FDA Code: NDN / 888.3027)

Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.