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The Aurora® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. The AURORA® Anterior Lumbar Plate System is indicated for in the treatment of lumbar and lumbosacral (L1-S1) spinal instability as a result of the following: - 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 ● - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) ● - tumor - pseudoarthrosis ● - failed previous fusion ● This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Aurora® Anterior Lumbar Plate System consists of an assortment of plates and screws. Implant components are available in a variety of sizes to suit the individual patient anatomies. The Aurora® Anterior Lumbar Plate System implants are manufactured from medical grade titanium alloy Ti-6A1-4V per ASTM F136/ISO 5832-3. The Aurora® Anterior Lumbar Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.