INDICATIONS FOR USE AND IMPORTANT SAFETY INFORMATION
Luna 3D® Interbody Fusion System
The Luna 3D Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D Interbody Fusion System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation. As with other spinal fusion devices and procedures, there are risks and considerations for use of the Luna 3D Interbody Fusion System. The risks include serious complications up to and including death. Please see the product labeling for a more detailed discussion of risks, contraindications, warnings and precautions.
Orbit Discectomy System
The Luna 2.0 Discectomy Instrument Set (LUN6210) is made up of reusable instruments that are intended to facilitate a complete discectomy in preparation for the Luna 3D Implant. The instruments are comprised of stainless steel and polymeric materials. The perforated instrument tray is comprised of aluminum and has various silicone and aluminum brackets to hold the instruments in place during handling and storage.
© 2018 Benvenue Medical Inc. All Rights Reserved. Benvenue Medical, Luna 3D and Orbit are registered trademarks of Benvenue Medical Inc.