INDICATIONS FOR USE AND IMPORTANT SAFETY INFORMATION
Luna XD Interbody Fusion System
The Luna XD Interbody Fusion System consists of a Luna XD Implant and associated accessories. This 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 XD Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of non-operative treatment prior to receiving the Luna XD Implant. The Luna XD 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 XD 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 Orbit Discectomy System is made up of reusable instruments that are intended to facilitate a complete discectomy in preparation for the Luna XD Implant.
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