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The Fixated Asfora BULLET CAGE® (FABC) is indicated for spinal fusion procedures in skeletally mature patients for the treatment of degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The FABC devices are used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. When used with the two fixation screws, the FABC System is a stand-alone system and requires no additional supplemental fixation. When used without the fixation screws, the FABC System should be used with supplemental fixation cleared for use in the lumbar spine. When only one device is implanted, the FABC System must be used with supplemental fixation cleared for use in the lumbar spine.

The Fixated Asfora BULLET CAGE® (FABC) System is comprised of a threaded titanium alloy interbody fusion cage and two optional fixation screws. The implants are available in an assortment of diameter and length combinations to accommodate a variety of anatomic requirements. The instrumentation for implantation is manufactured from medical grades of stainless steel per ASTM F899 with some having silicone handles.

The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (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.

The Asfora Anterior Cervical Plate System is composed of plates of varying lengths to accommodate surgical procedures from one to four levels. The plates are designed for application to the anterior aspect of the cervical spine and have three locking tabs to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters of 4.0mm (Variable Angle Implant Screw and Fixed Angle Implant Screw) and 4.4mm (Rescue Screw) and lengths of 12mm, 14mm and 16mm.

The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.

The Asfora Bullet Cage (ABC) is a threaded titanium alloy interbody fusion device (cage) with a threaded titanium end cap. The ABC is a threaded, self-tapping, bullet-shaped, hollow-body, device designed to immobilize adjacent vertebrae and promote arthrodesis (fusion) across the disc space. The Asfora Bullet Cage is available in ten sizes: 5 diameters (10mm, 12mm, 14mm, 16mm, and 18mm) and 2 lengths (21mm or 25mm).

The Asfora Bullet Cage™ (ABC) is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two levels from L2 to S1. The DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ABC cage devices are used with autogenous bone graft and are implanted via an open posterior approach. Patients should have had at least six (6) months of non-operative treatment prior to implant.

The Asfora Bullet Cage™ is comprised of two hollow, threaded, self-tapping titanium fusion devices (cages) with closed tapered medial ends. The distal end has a small orifice that can be closed with a threaded cap. There are six equidistant slit apertures along the longitudinal axis of the device for placement of autogenous bone graft material. The cage has large cutting threads, angled toward the proximal end. The Asfora Bullet Cage™ is available in ten sizes: 5 diameters (10mm, 12mm, 14mm, 16mm, and 18mm) and 2 lengths (21mm or 25mm). This device, with associated instrumentation is intended for use in posterior lumbar interbody fusion to immobilize adjacent vertebrae and promote arthrodesis (fusion) across the disc space.

Use of the Subdural Evacuating Port System Cranial Access Kit is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Subdural Evacuating Port System Cranial Access Kit is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

The Subdural Evacuating Port System Cranial Access Kit is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the Subdural Evacuating Port System Cranial Access Kit's "SEPS Components" are designed to promote gradual brain reexpansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir. The completeness of the Subdural Evacuating Port System Cranial Access Kit saves time and eliminates the need to gather supplies; this convenience can be critical in an emergency situation. The Subdural Evacuating Port System Cranial Access Kit is available in three (3) kit configurations: 1. SEPS-CA, Catalog # 11-0401-CA (Standard Kit) 2. SEPS-CAL, Catalog # 11-0401-CAL (Standard Kit with Lidocaine w/epinephrine) 3. SEPS-CAND, Catalog # 11-0401-CAND (Standard Kit without Lidocaine, ChloraPrep® One-Step, or PVP (Povidone-Iodine) ointment -- no drugs).