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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 manual locking mechanisms to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters from 4.0mm to 5.0mm (rescue) and lengths from 14mm to 16mm.

The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.

The SAMBA screw is a cannulated metallic bone screw designed to stabilize the sacroiliac (SI) joint. The SAMBA screw is composed of implant-grade Titanium, Ti-6Al-4V ELI, conforming to ASTM F-136. The SAMBA screw is 9 mm in diameter and offered in 25-50 mm lengths with multiple longitudinal slots on its shaft. Each slot set consists of four (4) holes oriented 90 degrees apart around the circumference of the screw at specified axial location. It will be provided as sterile, single units packaged in a sealed tray and pouch. The screw is a single use device and is not intended to be resterilized.

The Medical Designs Hand Drill is intended for use in Neurosurgical procedures and for use with Medical Designs' Subdural Evacuating Port System Kit (S.E.P.S), Catalog # 11-9901. The Hand Drill is not intended for any use other than that indicated.

The hand drill consists of a black ABS plastic housing, glass filled nylon handle and ABS plastic handle knob. The hand drill has lubricated aluminum gears and a ¼" spring loaded, chrome plated steel, 3-jaw chuck assembly. The hand drill is a single-use disposable device. It is sterilized using gamma radiation.