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The LEUCADIA™ 4.5 mm Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: 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, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.

The Leucadia™ 4.5 mm Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Leucadia™ 4.5 mm Pedicle Screw System consists of 4.5 mm diameter screws, which are available in 7 different lengths: 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, and 55 mm. All sizes are able to receive 5.5mm connecting rods only. The Leucadia™ 4.5 mm Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent. The Leucadia™ 4.5 mm Pedicle Screw System is a temporary implant system intended to be removed after solid fusion has occurred. Leucadia™ 4.5 mm Pedicle Screw System implant components are an addition to the existing Leucadia™ Pedicle Screw System (K110588 - S/E May 25, 2011). It should not be used with components from any other manufacturer. As with all orthopedic implants, Leucadia™ 4.5 mm Pedicle Screw System components should not be reused.

The LEUCADIA AutoLok™ Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: 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, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.

The Leucadia AutoLok™ Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Leucadia AutoLok™ Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The Multi-axial AutoLok™ screws are supplied in 5mm, 6mm, 7mm and 8 mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The unique pedicle screw and set screw interface is designed to prevent backout of the set screw from the construct. The Leucadia AutoLok™ Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent. The Leucadia AutoLok™ Pedicle Screw System is a temporary implant system, intended to be removed after solid fusion has occurred. Leucadia AutoLok™ Pedicle Screw System implant components should not be used with components from any other system or manufacturer. As with all orthopedic implants, Leucadia AutoLok™ Pedicle Screw System components should not be reused.

The LEUCADIA™ MIS Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: 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, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.

The Leucadia™ MIS Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Leucadia™ MIS Pedicle Screw System consists of a variety of rods and cannulated screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Multi-axial implant screws are supplied in 5mm, 6mm, and 7mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The ø1.7mm cannulation allows the screws to be implanted over a guidewire in a "mini open" or minimally invasive procedure. The Leucadia™ MIS Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent. The Leucadia™ MIS Pedicle Screw System is a temporary implant system, intended to be removed after solid fusion has occurred. Leucadia™ MIS Pedicle Screw System implant components should not be used with components from any other system or manufacturer. As with all orthopedic implants, Leucadia™ MIS Pedicle Screw System components should not be reused.

The DEL MAR® Monoaxial Pedicle Screw System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: 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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The Del Mar® Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Del Mar® Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor-made to fit the patient's individual anatomy. Monoaxial screws are supplied in winged and non-winged configurations, in a variety of length, ranging from 30 mm to 100 mm and in 5 mm, 6 mm, 7 mm, 8mm and 9 mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. Pre-bent rods are available in 10 mm increments from 30 to 120 mm in length. Additional components, such as a Single Piece Set Screw, Cobalt Chrome Rods ranging from 400 mm to 600 mm and several types of Deformity Connectors have been added. The Del Mar® Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136 and Cobalt Chrome alloy per ASTM F1058.

The LAGUNA® Pedicle Screw System is intended to be used as an adjunct to fusion in skeletally mature patients using autograft or allograft in posterior, non-cervical fixation for the following conditions: 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, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.

The LAGUNA® Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The LAGUNA® Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Polyaxial screws are supplied in winged and non-winged configurations, in a variety of different length, ranging from 30 mm to 100 mm and 5 mm, 6 mm, 7 mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The LAGUNA® Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.

The LEUCADIA™ Pedicle Screw System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: severe spondylolisthesis (grade 3 and 4) at L5-S1; degenerative spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The LEUCADIA™ Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The LEUCADIA™ Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Polyaxial screws are supplied in winged and non-winged configurations, in a variety of length, ranging from 30 mm to 100 mm and in 5 mm, 7 mm. 8mm and 9 mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. Pre-bent rods are available in 10 mm increments, ranging from 30 to 120 mm in length. The LEUCADIA™ Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.