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The NOVA Minimally Invasive System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) 2. Spondylolisthesis, 3. Trauma (i.e., fracture or dislocation), 4. Spinal stenosis. 5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6. Tumor, 7. Pseudoarthrosis, and 8. Failed previous fusion

The NOVA Minimally Invasive System consists of cannulated polyaxial screw, straight and pre-bent rods and set screws. The components are manufactured from titanium alloy per ASTM F136. The screws range in diameter from 5.5 mm to 7.0 mm and in length from 20 mm to 70 mm. The implants are not compatible with components or metal from any other manufacturer's system. The NOVA Minimally Invasive System can be used for both percutaneous and mini-open surgery

The COMET Lumbar Interbody Fusion Cage is indicated for use in intervertebral body fusion of the Spine. The COMET Lumbar Interbody Fusion Cage is inserted via a transforaminal posterior lumbar fusion procedures in skeletally mature patients with degenerative disc disease (DDD defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) and intended for use with autogenous bone graft at one or two contiguous levels of the lumbosacral spine (L2-S1). The COMET Lumbar Interbody Fusion Cage is intended to be used with supplemental fixation systems cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The COMET Lumbar Interbody Fusion Cage is a hollow, bullet-shaped PEEK cage (per ASTM F2026) with three Tantalum marker pins (per ASTM F560). It is indicated for use in skeletally mature patients for the lumbar spine intervertebral fusion. It is angulated 4°to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle.) The Cage devices are offered in a variety of different sizes with varying footprint dimensions to accommodate a multitude of anatomical needs. The implant has serrations on the top and bottom for fixation and the hollow space of the implant is intended to hold autogenous bone graft for fusion purposes. The COMET Lumbar Interbody Fusion Cage is supplied "Sterile".

The Facilis™ Spinal System is intended for posterior, non-cervical fixation to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion. The Facilis™ Spinal System is to be used with autograft and/or allograft.

The Facilis™ Spinal System is a system that is indicated for multiple types of spinal fusion procedures (please see Section IV). All components are made from titanium alloy Titanium-6 Aluminum-4 Vanadium (Ti-6AL-4V), a biocompatible material which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, hooks and accessory connection components. The Facilis™ Spinal Systems are supplied "Non-Steriled" and must be sterilized before use.

The NOVA Minimally Invasive System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), 2. Spondylolisthesis, 3. Trauma (i.e., fracture or dislocation) 4. Spinal stenosis, 5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6. Tumor, 7. Pseudoarthrosis, and 8. Failed previouis fusion

The NOVA Minimally Invasive System consists of cannulated polyaxial screws, straight and pre-bent rods, and set screws. The components are manufactured from titanium alloy per ASTM F136. The screws range in diameter from 5.5 mm to 7.0 mm and in length from 20 mm to 70 mm. The implants are not compatible with components or metal from any other manufacturer's system. The NOVA Minimally Invasive System can be used for both percutaneous and mini-open surgerv.

The FacilisTM Spinal System is a non- cervical, pedicle screw system intended to provide posterior, non-cervical immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). The FacilisTM Spinal System is also indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the implant fixed or attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Facilis "14 Spinal System is a system that is indicated for multiple types of spinal fusion procedures (please see Section IV). All components are made from titanium alloy Titanium-6 Aluminum-4 Vanadium (Ti-6AL-4V), a biocompatible material which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, hooks and accessory connection components. The Facilis™ Spinal Systems are supplied "Non-Steriled" and must be sterilized before use.