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The Testa™ TP Pivoting Spacer System with TiCell® Nano Advanced Surface Technology is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Testa™ TP Pivoting Spacer System is to be used with autograft bone and/or allogenic bone graft composed of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Testa™ TP Pivoting Spacer System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Testa™ TP Pivoting Spacer System consists of new interbody implants that are provided sterile and intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The system is provided in a range of sizes to accommodate the anatomic needs for range of patients and is designed with a central graft window to accommodate graft material. The implant features TiCell® Nano Advanced Surface Technology, a proprietary etched surface with micro and nano-scale features, on the superior and inferior latticed surfaces. This is intended to help with resistance to migration and to facilitate fusion. The components of the implant are fabricated from Titanium-6 Aluminum-4 Vanadium ELI (Ti-6Al-4V ELI) conforming to ASTM F3001 and ASTM F136.

When used with pedicle screw fixation systems, the Annex® 2 Adjacent Level 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). The Annex® 2 Adjacent Level System can be linked to 4.75 mm, 5.5 mm, and/or 6.0 mm diameter rods of the following systems: CapSure®, Sniper® or Salvo® Spine Systems.

The Annex® 2 Adjacent Level System consists of a selection of non-sterile, single-use locking screws, adjacent level devices, and connectors for attachment to an existing pedicle spinal fixation construct to extend a rigid spinal construct. The Annex® 2 Adjacent Level System components are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing between existing screw and rod hardware. The implant components of this system are manufactured from titanium (ASTM F67)), titanium alloy (Ti-6Al-4V ELI (ASTM F136)), and cobalt-chromium (CoCr (ASTM F1537)).

The Salvo® Robotic Navigation Instruments are indicated for use during the preparation and placement of Salvo® Spine System screws in open or minimally invasive procedures. The Salvo® Robotic Navigation Instruments are specifically designed for use with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

The Salvo® Robotic Navigation Instruments are surgical instruments that are designed to be used with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform. These instruments are intended to facilitate the placement of screws during spinal surgery. The instruments are reusable and offered as non-sterile, to be cleaned and steam sterilized by the end user.

The Salvo® Spine 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used in a percutaneous approach with minimally invasive surgery (MIS) instrumentation, the Salvo® Spine 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Salvo® Spine System is a thoracolumbosacral pedicle screw system designed through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V EL) per ASTM F136, commercially pure titanium per ASTM F67, cobaltchromium alloy per ASTM F 1537, and PEEK-OPTIMA LT1 with BaSO4. The System consists of a variety of screws, rods, and connectors that create a rigid construct as an adjunct to fixation and stabilization of the thoracic, lumbar, and sacral spine.

The Exceed™ Biplanar Expandable Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Exceed™ Biplanar Expandable Interbody System is to be used with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. The Exceed™ Biplanar Expandable Interbody System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Exceed™ Biolanar Expandable Interbody System is a lumbar intervertebral body fusion device fabricated from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implant is provided unexpanded with a nose tapered in both the lateral and vertical planes, and is expanded in situ using the Exceed™ Inserter. The implant has a microscopic roughened surface with micro and nano-scale features on the superior and inferior surfaces for resistance to migration and to facilitate fusion. The implant is provided in different heights, lengths, and lordotic angles to accommodate the anatomical needs for a range of patients, and is designed to accommodate autogenous and/or allogenic bone graft material.

The Salvo® Spine 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: degenerative disc disease; spondylolisthesis; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Salvo® Spine System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136, commercially pure titanium per ASTM F67, cobalt-chromium alloy per ASTM F1537 and PEEK-OPTIMA. The Salvo® Spine System consists of a variety of screws, rods, and connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.

The Salvo® Spine 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Salvo® Spine System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium per ASTM F67, cobalt-chromium alloy per ASTM F1537, and PEEK-OPTIMA LT1 per ASTM F2026. The Salvo® Spine System consists of a variety of screws, rods, and connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.

The Spine Wave® Navigated Instruments are intended to be used during the preparation and placement of Spine Wave screws (Sniper® Spine System, CapSure® Spine System, Proficient® Posterior Cervical Spine System, or the Salvo™ Spine System) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The Spine Wave® Navigated Instruments are designed for use with the Medtronic StealthStation® System.

The Spine Wave® Navigated Instruments are reusable, manual, surgical instruments made from stainless steel. These instruments are to be used with the Medtronic StealthStation® System via the Medtronic NavLock™ Tracker to facilitate screw placement during cervicothoracic and thoracolumbosacral surgeries. New instruments are being added to allow use with Salvo™ Spine System screws.

The Salvo™ Spine 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyhosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The modified Salvo™ Spine System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136, commercially pure titanium per ASTM F67, and cobalt-chromium alloy per ASTM F1537. The Salvo™ Spine System consists of a variety of screws, rods, and cross-connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.

The Salvo™ Spine 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Salvo™ Spine System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium per ASTM F67, and cobalt-chromium alloy per ASTM F1537. The Salvo™ Spine System consists of a variety of screws, rods, and cross-connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.