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The ChoiceSpine Boomerang™ Anterior Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. WARNING: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The ChoiceSpine Boomerang™ Anterior Cervical Plate system is intended for anterior screw fixation to the cervical spine. The system consists of a variety of bone plates and screws made from titanium alloy (T-6Al-4V ELI) per ASTM F136 and a set of instruments made from stainless steels (455, 465 and 17-4) per ASTM A564 and ASTM F899. The system components are provided non-sterile and must be steam sterilized by the user prior to use.

The ChoiceSpine Stealth™ Cervical Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc space to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in sketally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stealth™ Cervical Spacer System is to be used with supplemental fixation and with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion.

The ChoiceSpine Stealth™ Cervical Spacer System's implants have a basic oval shape with a hollow center for placement of bone graft. The superior and inferior surfaces have angled ridges, or "teeth," for resisting migration. The spacers are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements. The implants are made from either titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Materials Class C) or polyetheretherketone (PEEK-OPTIMA® polymer, Invibio®) per ASTM F2026 with tantalum markers per ASTM F560. Both implants will be provided sterile. Instruments will be provided non-sterile but will be steam sterilized before use. The instrumentation is made from 455/465 SS per ASTM A564 and 17-4 SS per ASTM F899.